ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2015-00187
- Event Type
- Injury
- Date Received
- September 24, 2015
- Date of Event
- April 27, 2015
- Report Date
- October 23, 2015
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- PMA / PMN Number
- P100022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PMA/510(K) # P100022/S100. THE (B)(4) STENT OF LOT NUMBER C972172 WAS IMPLANTED IN THE PATIENT AND IS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THESE WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: DIAGNOSTIC ANGIOGRAPHY PERFORMED 8 DAYS PRIOR TO INTERVENTION ((B)(6) 2014), ANGIOGRAPHY FROM ZILVER PTX IMPLANTATION (9/26/14), AND SECONDARY INTERVENTION ANGIOGRAPHY 7 MONTHS POST IMPLANTATION (4/27/15) ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. SECONDARY INTERVENTION SEVEN MONTHS LATER WAS PERFORMED THROUGH PROXIMAL RIGHT SFA ANTEGRADE ACCESS. THE PREVIOUSLY FOCAL PROXIMAL 50% SFA DIAMETER STENOSIS HAD LENGTHENED TO INVOLVE MORE THAN 50% OF THE PROXIMAL SFA¿S LENGTH. THE MID SFA HAD OCCLUDED AT THE SITE OF THE PRIOR MID PROXIMAL 40% SFA STENOSIS. THE OCCLUSION EXTENDED THROUGH THE STENT AND TERMINATED JUST INFERIOR THE PREVIOUS 60% DISTAL SFA STENOSIS. THE POPLITEAL ARTERY WAS DIFFUSELY SMALL LIKELY FROM DE-COMPRESSIVE COLLAPSE. ANGIOGRAPHY AFTER CROSSING THE OCCLUSION DEMONSTRATED ATHEROSCLEROTIC OCCLUSION OF THE SFA PROXIMAL THE STENT, THROMBUS WITHIN THE STENT, AND ATHEROSCLEROTIC OCCLUSION DISTAL THE STENT. THE ENTIRE MID AND DISTAL SFA WAS ANGIOPLASTIED WITH SIGNIFICANT IMPROVEMENT EXCEPT JUST PROXIMAL TO THE STENT WHERE THE LUMEN REMAINED SIGNIFICANTLY COMPROMISED BY RECOILED AND DEEPLY DISSECTED PLAQUE. FILLING DEFECTS WITHIN THE PROXIMAL STENT WERE CONSISTENT WITH PERSISTENT THROMBUS. THE ENTIRE MID AND DISTAL SFA INCLUDING THE PTX STENT WAS THEN STENTED WITH A VERY LONG SMART STENT RESTORING THE LUMEN IN THE STENTED SEGMENT. PROXIMAL SFA AND THE PREVIOUSLY DESCRIBED POPLITEAL STENOSIS WERE NOT ADDRESSED. THE SMART STENT WAS MILDLY CONSTRAINED PROXIMAL THE PTX STENT. IMPRESSION: THE ZILVER PTX STENT OCCLUSION WAS THE RESULT OF ADJACENT ATHEROSCLEROTIC PROGRESSION AND NOT IN-STENT STENOSIS. THE STENT WAS PRIMARILY FILLED WITH THROMBUS UPON SECONDARY INTERVENTION AND COLLARED ON BOTH ENDS BY OCCLUSIONS RELATED TO STENOSES ADJACENT THE ORIGINAL PTX TARGET LESION. THE OCCLUSION PROXIMALLY WAS PRIMARILY PROGRESSIVE ATHEROSCLEROTIC PLAQUE WHILE DISTALLY IT WAS PRIMARILY DE-COMPRESSIVE VESSEL COLLAPSE. ATHEROSCLEROTIC DISEASE WAS AGGRESSIVE AND LONGSTANDING AS EVIDENCED NOT ONLY BY THE PROGRESSIVE LEG DISEASE BUT ALSO BY THE FAILED ILIAC STENTS NECESSITATING AORTA-BIFEMORAL BYPASS AND CONSISTENT WITH CONTINUING TOBACCO ABUSE.¿ CLARIFICATION WAS REQUESTED REGARDING THE CAUSE OF OCCLUSION AND THE FOLLOWING INFORMATION WAS PROVIDED: ¿THE STENT THROMBOSED SECONDARY TO NEW STENOSIS PROXIMAL THE STENT. SO STRICTLY SPEAKING THE STENT OCCLUDED WITH THROMBUS.¿ INFORMATION PROVIDED STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION, CAROTID DISEASE, HYPERCHOLESTEROLEMIA AND IS A SMOKER. THE PERCENT DIAMETER STENOSIS IN THE STUDY LESION WAS 85%. IMAGING AND FOLLOW UP INFORMATION PROVIDED, REVEALED THAT STENT OCCLUSION WAS THE RESULT OF THROMBUS WITHIN THE STENT AND ATHEROSCLEROTIC PROGRESSION PROXIMAL AND DISTAL THE STENT AND NOT IN-STENT STENOSIS. THE BELOW LIST INDICATES POTENTIAL RISK FACTORS THAT CAN GENERALLY CONTRIBUTE TO THE THROMBOSIS EVENT: PATIENT FACTORS HISTORY OF COAGULOPATHY/PRIOR THROMBOSIS (E.G., DVT) DIABETES, ESPECIALLY IF POORLY CONTROLLED CANCER/CHEMOTHERAPY ADVANCED AGE OBESITY, HYPERLIPIDEMIA, HYPERTENSION SMOKING LESION FACTORS LONG LESION, SMALL VESSEL DIAMETER, SEVERE CALCIFICATION LESION TOTALLY OCCLUDED PRIOR TO STENT PLACEMENT PLACEMENT FOR IN STENT RESTENOSIS PROCEDURE FACTORS RESIDUAL INFLOW, OUTFLOW, OR IN-SEGMENT STENOSIS OR DISSECTION POOR RUN OFF (I.E., BEYOND TRIFURCATION) MEDICATION FACTORS INADEQUATE PROCEDURAL HEPARINIZATION INADEQUATE LOADING DOSE OF ANTIPLATELET (TICLOPIDINE OR CLOPIDOGREL) INADEQUATE DAPT PRESCRIBED NON-RESPONDER TO THE APT, OR NON-COMPLIANT WITH PRESCRIBE REGIMEN FROM THE PATIENT¿S PRE-EXISTING CONDITIONS PROVIDED WITH THIS COMPLAINT, IT IS KNOWN THAT THE PATIENT HAD KNOWN POTENTIAL RISK FACTORS FOR THROMBOSIS SUCH AS ADVANCED AGE (74), HYPERTENSION AND HISTORY OF TOBACCO USE. IT CAN BE NOTED THAT ACCORDING TO THE PHYSICIAN AND INDEPENDENT REVIEWER, TOBACCO ABUSE CAUSED OR CONTRIBUTED TO THE OCCURRENCE. LESION FACTORS MAY ALSO HAVE CONTRIBUTED TO THE OCCURRENCE INCLUDING THE 85% DIAMETER STENOSIS IN THE LESION. THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS IMAGING REVEALED OCCLUSION DUE TO THROMBUS. IT IS UNLIKELY THAT THROMBOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION HOWEVER A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AND NO OTHER COMMENTS CAN BE MADE. IT MAY BE NOTED THAT ARTERIAL THROMBOSIS IS A 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. ACCORDING TO INFORMATION PROVIDED BALLOON ANGIOPLASTY AND STENT PLACEMENT WAS PERFORMED. NO ADVERSE EVENTS WERE EXPERIENCED BY THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING. PMA/510(K) # P100022/S100. THE (B)(4) STENT OF LOT NUMBER C972172 WAS IMPLANTED IN THE PATIENT AND IS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THESE WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: ¿FINDINGS: DIAGNOSTIC ANGIOGRAPHY PERFORMED 8 DAYS PRIOR TO INTERVENTION ((B)(6) 2014), ANGIOGRAPHY FROM ZILVER PTX IMPLANTATION ((B)(6) 2014), AND SECONDARY INTERVENTION ANGIOGRAPHY 7 MONTHS POST IMPLANTATION ((B)(6) 2015) ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. SECONDARY INTERVENTION SEVEN MONTHS LATER WAS PERFORMED THROUGH PROXIMAL RIGHT SFA ANTEGRADE ACCESS. THE PREVIOUSLY FOCAL PROXIMAL 50% SFA DIAMETER STENOSIS HAD LENGTHENED TO INVOLVE MORE THAN 50% OF THE PROXIMAL SFA¿S LENGTH. THE MID SFA HAD OCCLUDED AT THE SITE OF THE PRIOR MID PROXIMAL 40% SFA STENOSIS. THE OCCLUSION EXTENDED THROUGH THE STENT AND TERMINATED JUST INFERIOR THE PREVIOUS 60% DISTAL SFA STENOSIS. THE POPLITEAL ARTERY WAS DIFFUSELY SMALL LIKELY FROM DE-COMPRESSIVE COLLAPSE. ANGIOGRAPHY AFTER CROSSING THE OCCLUSION DEMONSTRATED ATHEROSCLEROTIC OCCLUSION OF THE SFA PROXIMAL THE STENT, THROMBUS WITHIN THE STENT, AND ATHEROSCLEROTIC OCCLUSION DISTAL THE STENT. THE ENTIRE MID AND DISTAL SFA WAS ANGIOPLASTIED WITH SIGNIFICANT IMPROVEMENT EXCEPT JUST PROXIMAL TO THE STENT WHERE THE LUMEN REMAINED SIGNIFICANTLY COMPROMISED BY RECOILED AND DEEPLY DISSECTED PLAQUE. FILLING DEFECTS WITHIN THE PROXIMAL STENT WERE CONSISTENT WITH PERSISTENT THROMBUS. THE ENTIRE MID AND DISTAL SFA INCLUDING THE PTX STENT WAS THEN STENTED WITH A VERY LONG SMART STENT RESTORING THE LUMEN IN THE STENTED SEGMENT. PROXIMAL SFA AND THE PREVIOUSLY DESCRIBED POPLITEAL STENOSIS WERE NOT ADDRESSED. THE SMART STENT WAS MILDLY CONSTRAINED PROXIMAL THE PTX STENT. IMPRESSION: THE ZILVER PTX STENT OCCLUSION WAS THE RESULT OF ADJACENT ATHEROSCLEROTIC PROGRESSION AND NOT IN-STENT STENOSIS. THE STENT WAS PRIMARILY FILLED WITH THROMBUS UPON SECONDARY INTERVENTION AND COLLARED ON BOTH ENDS BY OCCLUSIONS RELATED TO STENOSES ADJACENT THE ORIGINAL PTX TARGET LESION. THE OCCLUSION PROXIMALLY WAS PRIMARILY PROGRESSIVE ATHEROSCLEROTIC PLAQUE WHILE DISTALLY IT WAS PRIMARILY DE-COMPRESSIVE VESSEL COLLAPSE. ATHEROSCLEROTIC DISEASE WAS AGGRESSIVE AND LONGSTANDING AS EVIDENCED NOT ONLY BY THE PROGRESSIVE LEG DISEASE BUT ALSO BY THE FAILED ILIAC STENTS NECESSITATING AORTA-BIFEMORAL BYPASS AND CONSISTENT WITH CONTINUING TOBACCO ABUSE.¿ CLARIFICATION WAS REQUESTED REGARDING THE CAUSE OF OCCLUSION AND THE FOLLOWING INFORMATION WAS PROVIDED: ¿THE STENT THROMBOSED SECONDARY TO NEW STENOSIS PROXIMAL THE STENT. SO STRICTLY SPEAKING THE STENT OCCLUDED WITH THROMBUS.¿ INFORMATION PROVIDED STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION, CAROTID DISEASE, HYPERCHOLESTEROLEMIA AND IS A SMOKER. THE PERCENT DIAMETER STENOSIS IN THE STUDY LESION WAS 85%. IMAGING AND FOLLOW UP INFORMATION PROVIDED, REVEALED THAT STENT OCCLUSION WAS THE RESULT OF THROMBUS WITHIN THE STENT AND ATHEROSCLEROTIC PROGRESSION PROXIMAL AND DISTAL THE STENT AND NOT IN-STENT STENOSIS. THE BELOW LIST INDICATES POTENTIAL RISK FACTORS THAT CAN GENERALLY CONTRIBUTE TO THE THROMBOSIS EVENT: PATIENT FACTORS HISTORY OF COAGULOPATHY/PRIOR THROMBOSIS (E.G., DVT) DIABETES, ESPECIALLY IF POORLY CONTROLLED CANCER/CHEMOTHERAPY ADVANCED AGE OBESITY, HYPERLIPIDEMIA, HYPERTENSION SMOKING LESION FACTORS LONG LESION, SMALL VESSEL DIAMETER, SEVERE CALCIFICATION LESION TOTALLY OCCLUDED PRIOR TO STENT PLACEMENT PLACEMENT FOR IN STENT RESTENOSIS PROCEDURE FACTORS: RESIDUAL INFLOW, OUTFLOW, OR IN-SEGMENT STENOSIS OR DISSECTION. POOR RUN OFF (I.E., BEYOND TRIFURCATION). MEDICATION FACTORS: INADEQUATE PROCEDURAL HEPARINIZATION. INADEQUATE LOADING DOSE OF ANTIPLATELET (TICLOPIDINE OR CLOPIDOGREL). INADEQUATE DAPT PRESCRIBED. NON-RESPONDER TO THE APT, OR NON-COMPLIANT WITH PRESCRIBE REGIMEN. FROM THE PATIENT¿S PRE-EXISTING CONDITIONS PROVIDED WITH THIS COMPLAINT, IT IS KNOWN THAT THE PATIENT HAD KNOWN POTENTIAL RISK FACTORS FOR THROMBOSIS SUCH AS ADVANCED AGE (74), HYPERTENSION AND HISTORY OF TOBACCO USE. IT CAN BE NOTED THAT ACCORDING TO THE PHYSICIAN AND INDEPENDENT REVIEWER, TOBACCO ABUSE CAUSED OR CONTRIBUTED TO THE OCCURRENCE. LESION FACTORS MAY ALSO HAVE CONTRIBUTED TO THE OCCURRENCE INCLUDING THE 85% DIAMETER STENOSIS IN THE LESION. THE CUSTOMER COMPLAINT CAN BE CONFIRMED AS IMAGING REVEALED OCCLUSION DUE TO THROMBUS. IT IS UNLIKELY THAT THROMBOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION HOWEVER A DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AND NO OTHER COMMENTS CAN BE MADE. IT MAY BE NOTED THAT ARTERIAL THROMBOSIS IS A 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. ACCORDING TO INFORMATION PROVIDED BALLOON ANGIOPLASTY AND STENT PLACEMENT WAS PERFORMED. NO ADVERSE EVENTS WERE EXPERIENCED BY THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING.
PMA/510(K) # P100022/S100. THIS INCIDENT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE SECONDARY INTERVENTION CARRIED OUT (BALLOON ANGIOPLASTY AND STENT PLACEMENT) AS A RESULT OF OCCLUSION/RESTENOSIS AT THE SITE WHERE A ZILVER PTX STENT WAS INDWELLING. THE (B)(4) STENT OF LOT NUMBER C972172 WAS IMPLANTED IN THE PATIENT AND IS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. IMAGES ARE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. THE INVESTIGATION WILL BE UPDATED UPON RECEIPT OF IMAGING REVIEW AND A FOLLOW-UP MDR WILL BE SUBMITTED.. INFORMATION PROVIDED STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION, CAROTID DISEASE, HYPERCHOLESTEROLEMIA AND IS A SMOKER. THE PERCENT DIAMETER STENOSIS IN THE STUDY LESION WAS 85%. IT CAN BE NOTED THAT ACCORDING TO THE PHYSICIAN, SMOKING AND PRE-EXISTING CONDITIONS CAUSED OR CONTRIBUTED TO THE OCCURRENCE. 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 IMAGING REVIEW HAS NOT YET BEEN RECEIVED THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT 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 BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. NO FURTHER ADVERSE EVENTS WERE EXPERIENCED BY THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. PMA/510(K) # P100022/S100. THIS INCIDENT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE SECONDARY INTERVENTION CARRIED OUT (BALLOON ANGIOPLASTY AND STENT PLACEMENT) AS A RESULT OF OCCLUSION/RESTENOSIS AT THE SITE WHERE A ZILVER PTX STENT WAS INDWELLING. THE (B)(4) STENT OF LOT NUMBER C972172 WAS IMPLANTED IN THE PATIENT AND IS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WILL BE CARRIED OUT. IMAGES ARE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION. THE INVESTIGATION WILL BE UPDATED UPON RECEIPT OF IMAGING REVIEW AND A FOLLOW-UP MDR WILL BE SUBMITTED. INFORMATION PROVIDED STATED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING HYPERTENSION, CAROTID DISEASE, HYPERCHOLESTEROLEMIA AND IS A SMOKER. THE PERCENT DIAMETER STENOSIS IN THE STUDY LESION WAS 85%. IT CAN BE NOTED THAT ACCORDING TO THE PHYSICIAN, SMOKING AND PRE-EXISTING CONDITIONS CAUSED OR CONTRIBUTED TO THE OCCURRENCE. 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 IMAGING REVIEW HAS NOT YET BEEN RECEIVED THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT RESTENOSIS OF THE STENTED ARTERY IS A KNOWN POTENTIAL ADVERSE EVENT 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 BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. NO FURTHER ADVERSE EVENTS WERE EXPERIENCED BY THE PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # P100022/S100. THIS INCIDENT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE SECONDARY INTERVENTION CARRIED OUT (BALLOON ANGIOPLASTY AND STENT PLACEMENT) AS A RESULT OF OCCLUSION/RESTENOSIS AT THE SITE WHERE A ZILVER PTX STENT WAS INDWELLING. THE INFORMATION RECEIVED RELATING TO THIS EVENT IS CURRENTLY BEING INVESTIGATED. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS. PMA/510(K) # P100022/S100. THIS INCIDENT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE SECONDARY INTERVENTION CARRIED OUT (BALLOON ANGIOPLASTY AND STENT PLACEMENT) AS A RESULT OF OCCLUSION/RESTENOSIS AT THE SITE WHERE A ZILVER PTX STENT WAS INDWELLING. THE INFORMATION RECEIVED RELATING TO THIS EVENT IS CURRENTLY BEING INVESTIGATED. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
(B)(4): THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL EVENT DESCRIPTION AS FOLLOWS: ON (B)(6) 2014 - THE PATIENT UNDERWENT PRE-DILATATION OF THE STUDY LESION BEFORE ONE 6 MM X 40 MM ZILVER PTX V STUDY STENT (LOT # C972172) WAS PLACED VIA IPSILATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. 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. ON (B)(6) 2014 (35 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A PLANNED REVASCULARIZATION OF THE CONTRALATERAL SFA (NON-STUDY LEG) DUE TO ISCHEMIA. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. ON (B)(6) 2015 (213 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION IN THE STUDY LESION DUE TO OCCLUSION/RESTENOSIS. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE, AND CITED SMOKING AS A PRE-EXISTING CONDITION THAT CAUSED OR CONTRIBUTED TO THE EVENT.
(B)(4): THIS FOLLOW UP MDR IS BEING SUBMITTED TO PROVIDE DETAILS OF THE INVESTIGATION CONCLUSION. INITIAL EVENT DESCRIPTION AS FOLLOWS: ON (B)(6) 2014 - THE PATIENT UNDERWENT PRE-DILATATION OF THE STUDY LESION BEFORE ONE 6 MM X 40 MM ZILVER PTX V STUDY STENT (LOT # C972172) WAS PLACED VIA IPSILATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. 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. ON (B)(6) 2014 (35 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A PLANNED REVASCULARIZATION OF THE CONTRALATERAL SFA (NON-STUDY LEG) DUE TO ISCHEMIA. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. ON (B)(6) 2015 (213 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION IN THE STUDY LESION DUE TO OCCLUSION/RESTENOSIS. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE, AND CITED SMOKING AS A PRE-EXISTING CONDITION THAT CAUSED OR CONTRIBUTED TO THE EVENT.
PROTOCOL (B)(4), PATIENT (B)(6): ON (B)(6) 2014- THE PATIENT UNDERWENT PRE-DILATATION OF THE STUDY LESION BEFORE ONE 6 MM X 40 MM ZILVER® PTX® V STUDY STENT (LOT # C972172) WAS PLACED VIA IPSILATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. 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. ON (B)(6) 2014 (35 DAYS POST PROCEDURE), THE PATIENT UNDERWENT A PLANNED REVASCULARIZATION OF THE CONTRALATERAL SFA (NON-STUDY LEG) DUE TO ISCHEMIA. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. ON (B)(6) 2015 (213 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION IN THE STUDY LESION DUE TO OCCLUSION/RESTENOSIS. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE TREATING PHYSICIAN STATED THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE, AND CITED SMOKING AS A PRE-EXISTING CONDITION THAT CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633638 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |