ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2015-00251
- Event Type
- Injury
- Date Received
- November 23, 2015
- Date of Event
- August 22, 2015
- Report Date
- March 30, 2016
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PMA/510(K)#: P100022/S001. ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C994205 WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT WAS CONFIRMED THAT IMAGES WILL BE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION AND WILL BE SENT TO COOK RESEARCH INC. (CRI) FOR REVIEW. THE INVESTIGATION WILL BE UPDATED ONCE IMAGING REVIEW IS RECEIVED. REPORTABILITY WILL BE RE-ASSESSED AND A FOLLOW-UP MDR REPORT WILL THEN BE SUBMITTED IF REQUIRED. AVAILABLE INFORMATION STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION AND HYPERCHOLESTEROLEMIA. THE PATIENT ENROLLED IN THE STUDY TO TREAT A 100% DIAMETER STENOSIS IN THE LEFT DISTAL SFA. ON THE 12 MONTH FOLLOW UP, ULTRASOUND REVEALED THE STENT WAS OCCLUDED PROXIMAL TO AND WITHIN THE STUDY LESION. 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 SURFACE OF THE ZILVER PTX STENT IS COATED WITH THE DRUG (PACLITAXEL) TO HELP PREVENT SUBSEQUENT RESTENOSIS OF THE ARTERY. IT CAN BE THEREFORE STATED THAT IT IS VERY UNLIKELY THAT THE REPORTED RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. DUE TO LACK OF IMAGING NO OTHER COMMENTS CAN BE MADE. AS NO IMAGING WAS AVAILABLE AT THE TIME OF COMPLAINT INVESTIGATION, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT WORSENED CLAUDICATION AND RESTENOSIS OF THE STENTED ARTERY ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH 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. ACCORDING TO INFORMATION PROVIDED THROMBOLYSIS AND STENT PLACEMENT WAS PERFORMED. NO OTHER ADVERSE EVENTS WERE EXPERIENCE BY THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
PMA/510(K)#: P100022/S001. ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C994205 WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE 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, SECONDARY INTERVENTION 1 YEAR POST, AND 2 WEEK POST-SECONDARY INTERVENTION ULTRASOUND AND ABIS 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 THE 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 6X80M STENT AND THE PROXIMAL STENT WAS THE 7X100MM STENT. POST STENT ANGIOPLASTY ELIMINATED SIGNIFICANT RESIDUAL STENOSIS EVEN THOUGH THE HEAVILY CALCIFIED SEGMENT. MAXIMAL RESIDUAL DIAMETER STENOSIS WAS 20%. SMOOTH 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 AND RECONSTITUTED 2.5CM WITHIN THE DISTAL STENT END. AFTER ULTRASOUND ASSISTED THROMBOLYSIS, THE MAJORITY OF THE OCCLUSION HAD RESOLVED. IN-STENT STENOSIS WAS GREATEST IN THE ORIGINALLY PATENT DISTAL 2.5CM AT 67% MAXIMAL DIAMETER STENOSIS (1.7MM/4.7MM). IN THE ORIGINALLY OCCLUDED STENT, A 2.5CM IRREGULAR SEGMENT JUST PROXIMAL THE ORIGINALLY SEGMENT WAS NARROWED 47% MAXIMAL DIAMETER STENOSIS (2.6MM/4.9MM). OTHERWISE THE STENTS WERE FREE OF STENOSIS GREATER THAN 30%. THE OCCLUDED UNSTENTED SEGMENT 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. IMPRESSION: THE 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 NEOINTIMAL HYPERPLASIA ALONE WAS UNLIKELY TO CAUSE THROMBOSIS PARTICULARLY SINCE THE PATENT STENT DISTALLY WAS EVEN MORE STENOTIC. THE ADDUCTOR CANAL SEGMENT WAS MOST LIKELY TO BEND AND TWIST WITH KNEE FLEXION AS WELL AS KINK BECAUSE OF THE SEVERE CALCIFICATION; 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 FINDING RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED; SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE INTERIOR END OF THE DISTAL STENT DEVELOPED MODERATE TO SEVERE NEOINTIMAL HYPERPLASIA. NO STENT FRACTURE, KINK, OR DEFECT WAS OBSERVED.¿ ENGINEERING INPUT WAS REQUESTED FOR SIMILAR COMPLAINTS, REGARDING THE FINDINGS RELATIVE TO THE DESIGN/PERFORMANCE OF THE DEVICE AND THE FOLLOWING COMMENTS WERE RECEIVED: ¿RESTENOSIS IS CAUSED BY AN EXAGGERATED HEALING RESPONSE TO ARTERIAL INJURY AS A RESULT OF MECHANICAL DAMAGE FROM THE ANGIOPLASTY/STENTING PROCEDURE. THE POTENTIAL CAUSE OF RESTENOSIS IS NOT DIRECTLY RELATED TO THE DESIGN OF THE DEVICE AND THEREFORE CANNOT BE REDUCED FURTHER BY DESIGN. ARTERIAL INJURY IS AN UNAVOIDABLE OUTCOME FROM THE ANGIOPLASTY/STENTING PROCEDURE. ANGIOPLASTY ALONE CAN CAUSE ARTERIAL INJURY LEADING TO RESTENOSIS. THEREFORE RESTENOSIS CAUSED BY THE ANGIOPLASTY/STENTING PROCEDURE POSES NO GREATER RISK THAN ANGIOPLASTY ALONE. IN FACT, OUR CLINICAL STUDY RESULTS INDICATE THAT THE RISK OF RESTENOSIS WHEN THE ZILVER PTX STENT IS USED IS SIGNIFICANTLY LOWER THAN WHEN ANGIOPLASTY ALONE IS PERFORMED, OR WHEN STENTING WITH A BARE ZILVER STENT IS PERFORMED. AS DETERMINED BY (RISK/BENEFIT ANALYSIS) (B)(4) THE CLINICAL BENEFITS OF THE ZILVER PTX DRUG-ELUTING STENT SYSTEM OUTWEIGH THE RISKS TO THE PATIENT.¿ ACCORDING TO THE IMAGING REVIEW THE OCCLUSION WAS PRIMARILY THROMBOTIC FROM A COMBINATION OF NEOINTIMAL HYPERPLASIA, A NEW STENOSIS PROXIMAL THE STENTS AND TRANSIENT STENT KINKING AT THE ADDUCTOR CANAL. THE DISTAL STENT¿S NEOINTIMAL HYPERPLASIA ALONE WAS UNLIKELY TO HAVE CAUSED THE THROMBOSIS PARTICULARLY SINCE THE PATENT STENT DISTALLY WAS EVEN MORE STENOTIC. THE MOST SEVERE CALCIFICATION WAS LOCATED AT THE ADDUCTOR CANAL. ACCORDING TO THE INDEPENDENT REVIEWER, THE ADDUCTOR CANAL SEGMENT WAS MOST LIKELY TO BEND AND TWIST WITH KNEE FLEXION AS WELL AS KINK BECAUSE OF THE SEVERE CALCIFICATION. THE FOLLOWING CLINICAL INPUT WAS RECEIVED RELATING TO THE FINDINGS OF THE IMAGE REVIEW: ¿RESTENOSIS DEPENDS ON THE DEFINITION. IT WAS 66% SO IT DEPENDS ON WHAT ONE WOULD CALL SIGNIFICANT¿..THAT BEING SAID THE DISTAL STENT NEOINTIMAL HYPERPLASIA LIKELY DID NOT CAUSE THE THROMBOSIS. THE THROMBOSIS WAS LIKELY PRIMARILY THE RESULT OF TRANSIENT STENT KINKING. AS IT IS STATED IN IMPRESSIONS, HAD THE DISTAL STENT INTIMAL HYPERPLASIA BEEN THE CAUSE IT WOULD HAVE THROMBOSED AT THE POINT OF GREATEST STENOSIS RATHER THAN ABOVE WHERE THE NEOINTIMAL HYPERPLASIA WAS LESS SEVERE. SOME OTHER REASON MUST HAVE CAUSE THE OCCLUSION AND IN THIS LOCATION WITH SEVERE VESSEL CALCIFICATION IT IS USUALLY KINKING AT THE ADDUCTOR CANAL. UNFORTUNATELY IT IS NOT POSSIBLE TO ASSESS TRANSIENT STENT KINKING UNLESS WE ARE PROVIDED IMAGES OF IT.¿.SECOND THE PROXIMAL STENT THROMBOSED SECONDARY TO THE KINK BELOW AND THE STENOSIS ABOVE. PROXIMAL STENT INSTENT STENOSIS WAS LESS THAN 30%.¿ BASED ON THE IMAGING REVIEW, THE CUSTOMER COMPLAINT CAN BE CONFIRMED. ACCORDING TO THE INDEPENDENT REVIEWER, THE THROMBOSIS WAS LIKELY PRIMARILY THE RESULT OF TRANSIENT STENT KINKING. THE NEOINTIMAL HYPERPLASIA LIKELY DID NOT CAUSE THE THROMBOSIS. IT IS UNLIKELY THAT THE REPORTED THROMBOSIS OCCURRED DUE TO ZILVER PTX MALFUNCTION. THE MOST LIKELY CAUSE OF THE OCCURRENCE WAS THE PATIENT¿S CONDITION. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT MAY BE NOTED THAT ARTERIAL THROMBOSIS AND RESTENOSIS OF THE STENTED ARTERY ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH 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. ACCORDING TO INFORMATION PROVIDED THROMBOLYSIS AND STENT PLACEMENT WAS PERFORMED. NO OTHER ADVERSE EVENTS WERE EXPERIENCED BY THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
(B)(6). 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 WAS COMPLETED. THE TWELVE MONTH FOLLOW-UP X-RAY WAS NOT COMPLETED. THE ULTRASOUND REVEALED THE STENT WAS OCCLUDED PROXIMAL TO AND WITHIN THE STUDY LESION. CORE LAB ANALYSIS IS NOT YET AVAILABLE. ON (B)(6) 2015 (369 DAYS POST PROCEDURE), THE TWELVE MONTH FOLLOW-UP CLINICAL ASSESSMENT WAS PERFORMED AND REVEALED A RIGHT AND LEFT ABI OF 1.33 AND 0.79 RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ZERO AND TWO, RESPECTIVELY. ON THE SAME DAY, THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO THE STUDY LESION [THE SITE HAS BEEN QUERIED REGARDING CLINICAL SYMPTOMS]. TREATMENT INCLUDED A THROMBOLYSIS AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT [SITE QUERIED] AND UNLIKELY TO BE RELATED TO THE STUDY PROCEDURE. CORE LAB ANALYSIS OF THE SECONDARY INTERVENTION ANGIOGRAPHY IS NOT YET AVAILABLE. AS PER THE ABOVE DESCRIPTION OF EVENT RECEIVED, TWO DEVICES ARE INVOLVED IN THIS INCIDENT. THIS REPORT ADDRESSES THE INVESTIGATION OF 1 X ZIV6-35-125-6-80-PTX DEVICE OF LOT#C994205. AN ADDITIONAL REPORT WILL BE SUBMITTED IN RELATION TO THE OTHER DEVICE REPORTED- REPORT REFERENCE NUMBER: 3001845648-2015-00250.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. PLEASE NOTE AS A RESULT OF THIS IMAGE REVIEW THE FAILURE MODE OF THIS EVENT HAS BEEN UPDATED FROM THROMBOSIS TO RESTENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774291 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |