ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2016-00181
- Event Type
- Injury
- Date Received
- July 14, 2016
- Date of Event
- March 23, 2016
- Report Date
- August 12, 2016
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002248905
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C994205 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ACCORDING TO INFORMATION PROVIDED, THE PATIENT UNDERWENT SECONDARY INTERVENTION FOR WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAM REVEALED EVIDENCE OF TOTAL OCCLUSION/RESTENOSIS OF THE LESION. IT CAN BE NOTED THAT WORSENING CLAUDICATION INDICATES PROGRESSION OF PERIPHERAL ARTERY DISEASE AND CAN ALSO BE ASSOCIATED WITH THE RESTENOSIS PROCESS. RESTENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PTA AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO OR AMPLIFIES THE RESTENOSIS PROCESS. IT MAY BE NOTED THAT THE SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG PACLITAXEL TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. BASED ON THE ABOVE, IT IS VERY UNLIKELY THAT THE REPORTED WORSENING CLAUDICATION/ RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION. THE MOST LIKELY CAUSE OF THIS EVENT WAS THE PATIENT¿S CONDITION. HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IT MAY BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE WORSENING CLAUDICATION/REST PAIN AND RESTENOSIS OF THE STENTED ARTERY ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C994205. ACCORDING TO THE COMPLAINT INFORMATION, TREATMENT INCLUDED THROMBOLYSIS AND STENT PLACEMENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C994205 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION AND WERE REVIEWED AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: IMPLANTATION ANGIOGRAPHY, ANGIOGRAPHY FROM A SECOND INTERVENTION 1 YEAR POST, AND 2 WEEK POST-SECONDARY INTERVENTION ULTRASOUND AND ABIS, AND ANGIOGRAPHY FROM A THIRD INTERVENTION PERFORMED 8 MONTHS AFTER THE SECOND INTERVENTION WERE PROVIDED WITH THE COMPLAINT REPORT. THE STUDY LESION WAS A 12CM LONG MID TO DISTAL SFA OCCLUSION WITH SEVERE CALCIFICATION OF THE DISTAL 4CM. THE SEVERE CALCIFICATION WAS LOCATED AT THE ADDUCTOR CANAL. DURING ANGIOPLASTY AND STENTING, IT WAS MOST RESISTANT AND SEVERE STENOSIS WITHIN THE OCCLUSION AND LIKELY REPRESENTED THE OCCLUSION¿S NIDUS. THE OCCLUSION WAS CROSSED WITH A CXI CATHETER, ANGIOPLASTIED TO 4MM, AND THEN STENTED WITH OVERLAPPING ZILVER PTX STENTS. THE DISTAL STENT WAS THE 6X80MM STENT AND THE PROXIMAL STENT WAS THE 7X100MM STENT. POST STENT ANGIOPLASTY ELIMINATED SIGNIFICANT RESIDUAL STENOSIS EVEN THOUGH THE HEAVILY CALCIFIED PLAQUE DISTAL THE STENT CAUSED 20% MAXIMAL DIAMETER STENOSIS. ONE VESSEL POSTERIOR TIBIAL ARTERY (PTA) RUNOFF WAS DEMONSTRATED TO THE DISTAL CALF. THE SFA OCCLUDED 3.5CM PROXIMAL THE STENTS. IT RECONSTITUTED 2.5CM INSIDE THE INFERIOR END OF THE DISTAL STENT. AFTER ULTRASOUND ASSISTED THROMBOLYSIS, THE MAJORITY OF THE OCCLUSION HAD RESOLVED. IN-STENT STENOSIS WAS GREATEST IN THE RECONSTITUTED 2.5CM SEGMENT WITHIN THE INFERIOR END OF THE DISTAL STENT. THE STENOSIS WAS 67% MAXIMAL DIAMETER STENOSIS (1.7MM/4.7MM). THROMBOLYSIS REVEALED MODEST NEOINTIMAL HYPERPLASIA WITHIN THE THROMBOSED PORTION OF THE DISTAL STENT. JUST SUPERIOR TO THE WHERE THE OCCLUSION HAD ORIGINALLY RECONSTITUTED, A 2.5CM IRREGULAR DISTAL STENT SEGMENT WAS NARROWED 47% (2.6MM/4.9MM). OTHERWISE THE REMAINING DISTAL STENT AND THE ENTIRE PROXIMAL STENT WERE FREE OF STENOSIS GREATER THAN 30%. THE SFA JUST PROXIMAL THE STENTS WAS NARROWED 66% MAXIMAL DIAMETER STENOSIS (2.0MM/5.9MM). ONE VESSEL PTA RUNOFF TO MID-CALF WAS STILL PRESENT PRE-THROMBOLYSIS. NO POST INTERVENTION DISTAL RUNOFF IMAGING WAS PROVIDED. THE ENTIRE SEGMENT WAS RELINED WITH A VIABAHN STENT THAT SPANNED THE OCCLUDED SEGMENT PROXIMAL THE STENTS AND DISTALLY TO THE POPLITEAL ARTERY. A SECOND SELF-EXPANDING STENT WAS IMPLANTED IN THE PROXIMAL VIABAHN. TWO WEEKS POST THE STENTS WERE WITHOUT STENOSIS ON ULTRASOUND AND THE ABIS NORMAL. THE THIRD INTERVENTION WAS PREFORMED APPROXIMATELY 6 MONTHS LATER. THE FIRST PROVIDED ANGIOGRAM DEMONSTRATED PATENCY OF THE ENTIRE STENTED SEGMENT. SINCE THE SEGMENT WAS REPORTEDLY THROMBOSED, THIS WAS LIKELY AFTER THROMBOLYSIS. INFLOW TO THE STENT WAS LIMITED BY A LARGE SEVERELY STENOTIC DISSECTED PLAQUE AND A STENOSIS WITHIN THE MOUTH OF THE MOST PROXIMAL STENT PLACED DURING THE SECOND INTERVENTION. THIS PLAQUE AND STENOSIS WERE STENTED WITH AN ADDITIONAL STENT. THE STENT COVERAGE WAS EXTENDED DISTALLY THROUGH THE POPLITEAL ARTERY TO THE KNEE JOINT LEVEL. NO FRACTURE OR STENT COMPRESSION WAS PRESENT INCLUDING THE COVERED STUDY STENTS. IMPRESSION: THE STENT OCCLUSION WAS PRIMARILY THROMBOTIC FROM LIKELY A COMBINATION OF NEOINTIMAL HYPERPLASIA, A NEW STENOSIS PROXIMAL THE STENTS, AND TRANSIENT STENT KINKING AT THE ADDUCTOR CANAL. THE DISTAL STENT THROMBOSED AT ITS MID-POINT WHICH WAS CENTRED AT THE ADDUCTOR CANAL. THIS SEGMENT WAS MOST LIKELY TO BEND AND TWIST WITH KNEE FLEXION AS WELL AS KINK BECAUSE OF SEVERE CALCIFICATION. THIS DISTAL STENT NEOINTIMAL HYPERPLASIA ALONE WAS UNLIKELY TO CAUSE THROMBOSIS. HAD NEOINTIMAL HYPERPLASIA BEEN THE PRIMARY CAUSE, THE STENT SHOULD HAVE THROMBOSED AT ITS INFERIOR END WHERE THE STENOSIS WAS MOST MODERATE TO SEVERE; NOT AT ITS MID-POINT WHERE THE STENOSIS WAS MILD TO MODERATE. THE 6X80MM DISTAL STENT, LOCATED AT THE ADDUCTOR CANAL, WOULD HAVE BEEN THE STENT MOST LIKELY TO KINK. THE PROXIMAL 7X100MM STENT WAS FREE OF SIGNIFICANT NEOINTIMAL HYPERPLASIA. IT THROMBOSED SECONDARY TO THROMBOSIS ADJACENT TO EACH END OF THE STENT. THE OCCLUSION OF THE STENTED SEGMENT TREATED AT THE THIRD INTERVENTION WAS RELATED TO THE NEW LESION PROXIMAL THE STENTS. THIS OCCLUSION WAS NOT RELATED TO THE STUDY STENTS AS THEY WERE COMPLETELY EXCLUDED BY THE COVERED STENTS IMPLANTED AT THE SECOND INTERVENTION. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT¿S ANATOMY WERE NOT OBSERVED. DISTAL RUNOFF WAS LIMITED TO THE PTA. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WAS OBSERVED. A NEW 66% MAXIMAL DIAMETER STENOSIS DEVELOPED PROXIMAL THE STENTS. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE INFERIOR END OF THE DISTAL STENT DEVELOPED MODERATE TO SEVERE NEOINTIMAL HYPERPLASIA. NO STENT FRACTURE, KINK, OR DEFECT WAS OBSERVED.¿ ACCORDING TO THE IMAGING REVIEW, THE OCCLUSION OF THE STENTED SEGMENT TREATED AT THE THIRD INTERVENTION WAS RELATED TO THE NEW LESION PROXIMAL THE STENTS. THIS OCCLUSION WAS NOT RELATED TO THE STUDY STENTS AS THEY WERE COMPLETELY EXCLUDED BY THE COVERED STENTS IMPLANTED AT THE SECOND INTERVENTION. CLARIFICATION WAS REQUESTED REGARDING THE INVOLVEMENT OF THE PTX STENTS AND THE FOLLOWING COMMENTS WERE PROVIDED: ¿THE PTX STENTS WERE NOT INVOLVED AND DID NOT CAUSE OR CONTRIBUTE TO THE OCCLUSION. THEY WERE COMPLETELY COVERED AT THE SECOND INTERVENTION AND THEREFORE NO LONGER PART OF THE PROCESS. THE ONLY WAY THEY COULD HAVE CONTRIBUTED TO THE SECOND OCCLUSION WAS IF THEY HAD FRACTURED AND SECONDARILY COMPRESSED THE COVERED STENT LINING THEM. THERE IS NO EVIDENCE OF THIS.¿ BASED ON THE IMAGING REVIEW, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED AS THE OCCLUSION WAS NOT RELATED TO THE PTX STENTS. IT CAN BE NOTED THAT, DURING THE 2ND INTERVENTION, A VIABHAN STENT AND A SELF-EXPANDING STENT WERE IMPLANTED. FURTHER INFORMATION WAS REQUESTED FROM THE INDEPENDENT REVIEWER REGARDING THE SELF-EXPANDING STENT AND THE FOLLOWING INFORMATION WAS RECEIVED: ¿THE STENT LIKELY WAS A ZILVER STENT HOWEVER SMART/INNOVA STENTS AND PROTÉGÉ STENTS BOTH HAVE 4 MARKERS ON THE ENDS AND CAN BE VERY INDISTINGUISHABLE. ALL I CAN SAY FOR SURE WAS THAT IT WAS NOT A COVERED STENT AND NOT A SUPERA STENT.¿. REFERENCE REPORT # 3001845648-2016-00205. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C994205. ACCORDING TO THE COMPLAINT INFORMATION, TREATMENT INCLUDED THROMBOLYSIS AND STENT PLACEMENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C994205 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION AND WERE REVIEWED AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: IMPLANTATION ANGIOGRAPHY, ANGIOGRAPHY FROM A SECOND INTERVENTION 1 YEAR POST, AND 2 WEEK POST-SECONDARY INTERVENTION ULTRASOUND AND ABIS, AND ANGIOGRAPHY FROM A THIRD INTERVENTION PERFORMED 8 MONTHS AFTER THE SECOND INTERVENTION WERE PROVIDED WITH THE COMPLAINT REPORT. THE STUDY LESION WAS A 12CM LONG MID TO DISTAL SFA OCCLUSION WITH SEVERE CALCIFICATION OF THE DISTAL 4CM. THE SEVERE CALCIFICATION WAS LOCATED AT THE ADDUCTOR CANAL. DURING ANGIOPLASTY AND STENTING, IT WAS MOST RESISTANT AND SEVERE STENOSIS WITHIN THE OCCLUSION AND LIKELY REPRESENTED THE OCCLUSION¿S NIDUS. THE OCCLUSION WAS CROSSED WITH A CXI CATHETER, ANGIOPLASTIED TO 4MM, AND THEN STENTED WITH OVERLAPPING ZILVER PTX STENTS. THE DISTAL STENT WAS THE 6X80MM STENT AND THE PROXIMAL STENT WAS THE 7X100MM STENT. POST STENT ANGIOPLASTY ELIMINATED SIGNIFICANT RESIDUAL STENOSIS EVEN THOUGH THE HEAVILY CALCIFIED PLAQUE DISTAL THE STENT CAUSED 20% MAXIMAL DIAMETER STENOSIS. ONE VESSEL POSTERIOR TIBIAL ARTERY (PTA) RUNOFF WAS DEMONSTRATED TO THE DISTAL CALF. THE SFA OCCLUDED 3.5CM PROXIMAL THE STENTS. IT RECONSTITUTED 2.5CM INSIDE THE INFERIOR END OF THE DISTAL STENT. AFTER ULTRASOUND ASSISTED THROMBOLYSIS, THE MAJORITY OF THE OCCLUSION HAD RESOLVED. IN-STENT STENOSIS WAS GREATEST IN THE RECONSTITUTED 2.5CM SEGMENT WITHIN THE INFERIOR END OF THE DISTAL STENT. THE STENOSIS WAS 67% MAXIMAL DIAMETER STENOSIS (1.7MM/4.7MM). THROMBOLYSIS REVEALED MODEST NEOINTIMAL HYPERPLASIA WITHIN THE THROMBOSED PORTION OF THE DISTAL STENT. JUST SUPERIOR TO THE WHERE THE OCCLUSION HAD ORIGINALLY RECONSTITUTED, A 2.5CM IRREGULAR DISTAL STENT SEGMENT WAS NARROWED 47% (2.6MM/4.9MM). OTHERWISE THE REMAINING DISTAL STENT AND THE ENTIRE PROXIMAL STENT WERE FREE OF STENOSIS GREATER THAN 30%. THE SFA JUST PROXIMAL THE STENTS WAS NARROWED 66% MAXIMAL DIAMETER STENOSIS (2.0MM/5.9MM). ONE VESSEL PTA RUNOFF TO MID-CALF WAS STILL PRESENT PRE-THROMBOLYSIS. NO POST INTERVENTION DISTAL RUNOFF IMAGING WAS PROVIDED. THE ENTIRE SEGMENT WAS RELINED WITH A VIABAHN STENT THAT SPANNED THE OCCLUDED SEGMENT PROXIMAL THE STENTS AND DISTALLY TO THE POPLITEAL ARTERY. A SECOND SELF-EXPANDING STENT WAS IMPLANTED IN THE PROXIMAL VIABAHN. TWO WEEKS POST THE STENTS WERE WITHOUT STENOSIS ON ULTRASOUND AND THE ABIS NORMAL. THE THIRD INTERVENTION WAS PREFORMED APPROXIMATELY 6 MONTHS LATER. THE FIRST PROVIDED ANGIOGRAM DEMONSTRATED PATENCY OF THE ENTIRE STENTED SEGMENT. SINCE THE SEGMENT WAS REPORTEDLY THROMBOSED, THIS WAS LIKELY AFTER THROMBOLYSIS. INFLOW TO THE STENT WAS LIMITED BY A LARGE SEVERELY STENOTIC DISSECTED PLAQUE AND A STENOSIS WITHIN THE MOUTH OF THE MOST PROXIMAL STENT PLACED DURING THE SECOND INTERVENTION. THIS PLAQUE AND STENOSIS WERE STENTED WITH AN ADDITIONAL STENT. THE STENT COVERAGE WAS EXTENDED DISTALLY THROUGH THE POPLITEAL ARTERY TO THE KNEE JOINT LEVEL. NO FRACTURE OR STENT COMPRESSION WAS PRESENT INCLUDING THE COVERED STUDY STENTS. IMPRESSION: THE STENT OCCLUSION WAS PRIMARILY THROMBOTIC FROM LIKELY A COMBINATION OF NEOINTIMAL HYPERPLASIA, A NEW STENOSIS PROXIMAL THE STENTS, AND TRANSIENT STENT KINKING AT THE ADDUCTOR CANAL. THE DISTAL STENT THROMBOSED AT ITS MID-POINT WHICH WAS CENTRED AT THE ADDUCTOR CANAL. THIS SEGMENT WAS MOST LIKELY TO BEND AND TWIST WITH KNEE FLEXION AS WELL AS KINK BECAUSE OF SEVERE CALCIFICATION. THIS DISTAL STENT NEOINTIMAL HYPERPLASIA ALONE WAS UNLIKELY TO CAUSE THROMBOSIS. HAD NEOINTIMAL HYPERPLASIA BEEN THE PRIMARY CAUSE, THE STENT SHOULD HAVE THROMBOSED AT ITS INFERIOR END WHERE THE STENOSIS WAS MOST MODERATE TO SEVERE; NOT AT ITS MID-POINT WHERE THE STENOSIS WAS MILD TO MODERATE. THE 6X80MM DISTAL STENT, LOCATED AT THE ADDUCTOR CANAL, WOULD HAVE BEEN THE STENT MOST LIKELY TO KINK. THE PROXIMAL 7X100MM STENT WAS FREE OF SIGNIFICANT NEOINTIMAL HYPERPLASIA. IT THROMBOSED SECONDARY TO THROMBOSIS ADJACENT TO EACH END OF THE STENT. THE OCCLUSION OF THE STENTED SEGMENT TREATED AT THE THIRD INTERVENTION WAS RELATED TO THE NEW LESION PROXIMAL THE STENTS. THIS OCCLUSION WAS NOT RELATED TO THE STUDY STENTS AS THEY WERE COMPLETELY EXCLUDED BY THE COVERED STENTS IMPLANTED AT THE SECOND INTERVENTION. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT¿S ANATOMY WERE NOT OBSERVED. DISTAL RUNOFF WAS LIMITED TO THE PTA. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WAS OBSERVED. A NEW 66% MAXIMAL DIAMETER STENOSIS DEVELOPED PROXIMAL THE STENTS. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE INFERIOR END OF THE DISTAL STENT DEVELOPED MODERATE TO SEVERE NEOINTIMAL HYPERPLASIA. NO STENT FRACTURE, KINK, OR DEFECT WAS OBSERVED.¿ ACCORDING TO THE IMAGING REVIEW, THE OCCLUSION OF THE STENTED SEGMENT TREATED AT THE THIRD INTERVENTION WAS RELATED TO THE NEW LESION PROXIMAL THE STENTS. THIS OCCLUSION WAS NOT RELATED TO THE STUDY STENTS AS THEY WERE COMPLETELY EXCLUDED BY THE COVERED STENTS IMPLANTED AT THE SECOND INTERVENTION. CLARIFICATION WAS REQUESTED REGARDING THE INVOLVEMENT OF THE PTX STENTS AND THE FOLLOWING COMMENTS WERE PROVIDED: ¿THE PTX STENTS WERE NOT INVOLVED AND DID NOT CAUSE OR CONTRIBUTE TO THE OCCLUSION. THEY WERE COMPLETELY COVERED AT THE SECOND INTERVENTION AND THEREFORE NO LONGER PART OF THE PROCESS. THE ONLY WAY THEY COULD HAVE CONTRIBUTED TO THE SECOND OCCLUSION WAS IF THEY HAD FRACTURED AND SECONDARILY COMPRESSED THE COVERED STENT LINING THEM. THERE IS NO EVIDENCE OF THIS.¿ BASED ON THE IMAGING REVIEW, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED AS THE OCCLUSION WAS NOT RELATED TO THE PTX STENTS. IT CAN BE NOTED THAT, DURING THE 2ND INTERVENTION, A VIABHAN STENT AND A SELF-EXPANDING STENT WERE IMPLANTED. FURTHER INFORMATION WAS REQUESTED FROM THE INDEPENDENT REVIEWER REGARDING THE SELF-EXPANDING STENT AND THE FOLLOWING INFORMATION WAS RECEIVED: ¿THE STENT LIKELY WAS A ZILVER STENT HOWEVER SMART/INNOVA STENTS AND PROTÉGÉ STENTS BOTH HAVE 4 MARKERS ON THE ENDS AND CAN BE VERY INDISTINGUISHABLE. ALL I CAN SAY FOR SURE WAS THAT IT WAS NOT A COVERED STENT AND NOT A SUPERA STENT.¿ REFERENCE REPORT # 3001845648-2016-00193. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C994205. ACCORDING TO THE COMPLAINT INFORMATION, TREATMENT INCLUDED THROMBOLYSIS AND STENT PLACEMENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
(B)(6), THROMBOSIS OF THE STUDY LESION PROBABLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2014, THE LESION WAS PRE-DILATED WITH ONE INFLATION OF A 4 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS. ONE 6 MM X 80 MM AND ONE 7 MM X 100 MM ZILVER PTX V STUDY STENTS (LOT # C994205/C1003485) WERE PLACED IN THE LEFT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS VERY EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS, ONE INFLATION OF A 7 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS, AND ONE INFLATION OF A 10 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL, AND THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVDS WERE 7.0 MM AND 6.0 MM, RESPECTIVELY. CORE LAB ANALYSIS OF THE FINAL LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.41 MM, AN MLD OF 3.28 MM, AND 39.37% RESIDUAL STENOSIS. THERE WAS NO THROMBUS, PERFORATION, DISTAL EMBOLIZATION, OR DISSECTION NOTED. ON (B)(6) 2015 (177 DAYS POST-PROCEDURE), THE POST-PROCEDURE CLINICAL ASSESSMENT WAS PERFORMED. THE RIGHT AND LEFT ABIS WERE 1.19 AND 1.11 RESPECTIVELY. ON (B)(6) 2015 (361 DAYS POST PROCEDURE), THE TWELVE MONTH FOLLOW-UP ULTRASOUND AND FOLLOW-UP CLINICAL ASSESSMENT WAS COMPLETED. THE RIGHT AND LEFT ABIS WERE 1.33 AND 0.79 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. THE TWELVE MONTH FOLLOW-UP X-RAY WAS NOT COMPLETED. THE ULTRASOUND REVEALED THE STENT WAS OCCLUDED PROXIMAL TO, WITHIN, AND DISTAL TO THE STUDY LESION. CORE LAB ANALYSIS REVEALED PATENCY PROXIMAL TO, WITHIN AND DISTAL TO THE STUDY LESION. ON (B)(6) 2015 (369 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION FOR WORSENING CLAUDICATION, ULTRASOUND FINDINGS, AND THROMBOSIS. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND UNLIKELY TO BE RELATED TO THE STUDY PROCEDURE. CORE LAB ANALYSIS OF THE BASELINE LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.16 MM, AN MLD OF ZERO, AND 100% DIAMETER STENOSIS. THERE WAS NO THROMBUS NOTED. THE FINAL LESION MORPHOLOGY ANALYSIS IS NOT AVAILABLE. ON (B)(6) 2016 (583 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION FOR WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED EVIDENCE OF A TOTAL OCCLUSION/RESTENOSIS OF THE STUDY LESION. THE PRE-INTERVENTION CLINICAL ASSESSMENT REVEALED THAT THE RIGHT AND LEFT ABIS WERE 1.24 AND 0.42 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE. CORE LAB ANALYSIS IS NOT AVAILABLE. REFERENCE ALSO RELATED REPORTS 3001845648-2016-00182, 3001845648-2016-00250, 3001845648-2016-00251. A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH INTERVENTION AND EACH SUSPECT DEVICE.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO AN ERROR NOTED IN AN MDR REPORT REFERENCE NUMBER. REPORT # 3001845648-2016-00193 IS NOT RELATED TO THIS EVENT; THIS WAS AN ERROR. THIS REPORT # HAS BEEN REPLACED WITH REPORT # 3001845648-2016-00205. RELATED TO THE FOLLOWING REPORTS: 3001845648-2016-00205 & 3001845648-2016-00182 (THIRD INTERVENTION); 3001845648-2015-00250 & 3001845648-2015-00251 (SECOND INTERVENTION). INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: PROTOCOL 12-004, PT. (B)(6), THROMBOSIS OF THE STUDY LESION PROBABLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2014, THE LESION WAS PRE-DILATED WITH ONE INFLATION OF A 4 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS. ONE 6 MM X 80 MM AND ONE 7 MM X 100 MM ZILVER® PTX® V STUDY STENTS (LOT # C994205/C1003485) WERE PLACED IN THE LEFT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS VERY EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS, ONE INFLATION OF A 7 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS, AND ONE INFLATION OF A 10 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL, AND THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVDS WERE 7.0 MM AND 6.0 MM, RESPECTIVELY. CORE LAB ANALYSIS OF THE FINAL LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.41 MM, AN MLD OF 3.28 MM, AND 39.37% RESIDUAL STENOSIS. THERE WAS NO THROMBUS, PERFORATION, DISTAL EMBOLIZATION, OR DISSECTION NOTED. ON (B)(6) 2015 (177 DAYS POST-PROCEDURE), THE POST-PROCEDURE CLINICAL ASSESSMENT WAS PERFORMED. THE RIGHT AND LEFT ABIS WERE 1.19 AND 1.11 RESPECTIVELY. ON (B)(6) 2015 (361 DAYS POST PROCEDURE), THE TWELVE MONTH FOLLOW-UP ULTRASOUND AND FOLLOW-UP CLINICAL ASSESSMENT WAS COMPLETED. THE RIGHT AND LEFT ABIS WERE 1.33 AND 0.79 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. THE TWELVE MONTH FOLLOW-UP X-RAY WAS NOT COMPLETED. THE ULTRASOUND REVEALED THE STENT WAS OCCLUDED PROXIMAL TO, WITHIN, AND DISTAL TO THE STUDY LESION. CORE LAB ANALYSIS REVEALED PATENCY PROXIMAL TO, WITHIN AND DISTAL TO THE STUDY LESION. ON (B)(6) 2015 (369 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION FOR WORSENING CLAUDICATION, ULTRASOUND FINDINGS, AND THROMBOSIS. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND UNLIKELY TO BE RELATED TO THE STUDY PROCEDURE. CORE LAB ANALYSIS OF THE BASELINE LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.16 MM, AN MLD OF ZERO, AND 100% DIAMETER STENOSIS. THERE WAS NO THROMBUS NOTED. THE FINAL LESION MORPHOLOGY ANALYSIS IS NOT AVAILABLE. ON (B)(6) 2016 (583 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION FOR WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED EVIDENCE OF A TOTAL OCCLUSION/RESTENOSIS OF THE STUDY LESION. THE PRE-INTERVENTION CLINICAL ASSESSMENT REVEALED THAT THE RIGHT AND LEFT ABIS WERE 1.24 AND 0.42 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE. CORE LAB ANALYSIS IS NOT AVAILABLE.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF IMAGES RELATING TO THIS EVENT AND THE SUBSEQUENT REVIEW OF THESE IMAGES. RELATED TO THE FOLLOWING REPORTS: 3001845648-2016-00193 & 3001845648-2016-00182 (THIRD INTERVENTION); 3001845648-2015-00250 & 3001845648-2015-00251 (SECOND INTERVENTION). INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: (B)(6), THROMBOSIS OF THE STUDY LESION PROBABLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2014, THE LESION WAS PRE-DILATED WITH ONE INFLATION OF A 4 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS. ONE 6 MM X 80 MM AND ONE 7 MM X 100 MM ZILVER® PTX® V STUDY STENTS (LOT # C994205/C1003485) WERE PLACED IN THE LEFT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS VERY EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS, ONE INFLATION OF A 7 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS, AND ONE INFLATION OF A 10 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL, AND THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVDS WERE 7.0 MM AND 6.0 MM, RESPECTIVELY. CORE LAB ANALYSIS OF THE FINAL LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.41 MM, AN MLD OF 3.28 MM, AND 39.37% RESIDUAL STENOSIS. THERE WAS NO THROMBUS, PERFORATION, DISTAL EMBOLIZATION, OR DISSECTION NOTED. ON (B)(6) 2015 (177 DAYS POST-PROCEDURE), THE POST-PROCEDURE CLINICAL ASSESSMENT WAS PERFORMED. THE RIGHT AND LEFT ABIS WERE 1.19 AND 1.11 RESPECTIVELY. ON (B)(6) 2015 (361 DAYS POST PROCEDURE), THE TWELVE MONTH FOLLOW-UP ULTRASOUND AND FOLLOW-UP CLINICAL ASSESSMENT WAS COMPLETED. THE RIGHT AND LEFT ABIS WERE 1.33 AND 0.79 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. THE TWELVE MONTH FOLLOW-UP X-RAY WAS NOT COMPLETED. THE ULTRASOUND REVEALED THE STENT WAS OCCLUDED PROXIMAL TO, WITHIN, AND DISTAL TO THE STUDY LESION. CORE LAB ANALYSIS REVEALED PATENCY PROXIMAL TO, WITHIN AND DISTAL TO THE STUDY LESION. ON (B)(6) 2015 (369 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION FOR WORSENING CLAUDICATION, ULTRASOUND FINDINGS, AND THROMBOSIS. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND UNLIKELY TO BE RELATED TO THE STUDY PROCEDURE. CORE LAB ANALYSIS OF THE BASELINE LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.16 MM, AN MLD OF ZERO, AND 100% DIAMETER STENOSIS. THERE WAS NO THROMBUS NOTED. THE FINAL LESION MORPHOLOGY ANALYSIS IS NOT AVAILABLE. ON (B)(6) 2016 (583 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION FOR WORSENING CLAUDICATION. PRE-INTERVENTION ANGIOGRAPHY REVEALED EVIDENCE OF A TOTAL OCCLUSION/RESTENOSIS OF THE STUDY LESION. THE PRE-INTERVENTION CLINICAL ASSESSMENT REVEALED THAT THE RIGHT AND LEFT ABIS WERE 1.24 AND 0.42 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE. CORE LAB ANALYSIS IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447120 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | 10827002248905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |