ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2016-00169
- Event Type
- Injury
- Date Received
- July 4, 2016
- Date of Event
- June 6, 2016
- Report Date
- July 5, 2016
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002248905
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K)#: P100022/S001. THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C910446 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, 1 YEAR POST IMPLANTATION X-RAYS AND ULTRASOUND, AND 2 YEAR POST IMPLANTATION ULTRASOUND AND ABIS ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. THE TARGET LESION WAS A LONG MODERATE TO SEVERE, 65% (2MM/4.4MM), MID TO DISTAL SFA STENOSIS SUPERIMPOSED ON A BACK GROUND OF DIFFUSE MILD TO MODERATE, 25-50% STENOSIS. THE DISEASE WAS SO DIFFUSE THAN THE REFERENCE VESSEL DIAMETERS WERE ONLY SHORT SEGMENTS OF NORMAL ARTERY. THESE WERE NOT IMMEDIATELY ADJACENT THE TARGET LESION BUT WELL REMOVED. THE PROXIMAL REFERENCE VESSEL MEASURED IN THE PROXIMAL SFA WAS 4.3MM. THE DISTAL REFERENCE VESSEL MEASURED IN THE POPLITEAL ARTERY JUST SUPERIOR THE KNEE JOINT WAS 4.5MM. PLACEMENT OF THE CALIBRATION TAPE ON THE ANTERIOR THIGH PRODUCED A MAGNIFICATION ERROR OF 7%. THIS WAS VERIFIED BY CALIBRATING OFF THE ANGIOPLASTY BALLOON. THE STENTS WERE IMPLANTED FROM THE SFA POPLITEAL JUNCTION ACROSS THE ADDUCTOR CANAL THROUGH THE MID SFA. THE STENTS OVERLAPPED 2MM. THE ENTIRE STENTED LENGTH WAS 158MM. THE STENTED STENOSIS WAS COMPLETELY RELIEVED HOWEVER INFLOW AND OUTFLOW WAS LIMITED BY ADJACENT MILD TO MODERATELY NARROWED 4CM LONG SEGMENTS ADJACENT THE STENTS. PROXIMALLY THE LUMEN WAS NARROWED TO 2.9MM AND DISTALLY TO 3.4MM. ADDITIONALLY A 3MM STENOSIS WAS PRESENT IN THE PA AT THE KNEE JOINT. CONTINUOUS SINGLE VESSEL RUNOFF TO THE ANKLE WAS PROVIDED BY THE PERONEAL ARTERY. NO CONTINUOUS SINGLE VESSEL RUNOFF INTO THE FOOT WAS PRESENT AS BOTH THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES WERE OCCLUDED. THE PERONEAL ARTERY RECONSTITUTED THE DORSAL PEDIS ARTERY AT THE ANKLE TO PROVIDE RUNOFF INTO THE FOOT. THE POSTERIOR TIBIAL ARTERY OCCLUSION CONTINUED INTO THE FOOT. IMAGING OF THE RIGHT ILIOFEMORAL INFLOW WAS NOT PROVIDED. THE YEAR FOLLOW UP X-RAYS DEMONSTRATED AN ADDITIONAL STENT PLACED PROXIMAL TO THE ORIGINAL STENTS. THE NEW STENT WAS LIKELY AN 80MM ZILVER STENT EITHER 6 OR 7MM IN DIAMETER, DEPLOYED SLIGHTLY STRETCHED BY 5MM. IT OVERLAPPED THE ADJACENT STENT BY 6MM. NO EXTERNAL COMPRESSION, KINK OR FRACTURE WAS PRESENT. ULTRASOUND PERFORMED ON THE SAME DATE DEMONSTRATED WIDELY PATENT STENTS. ULTRASOUND PERFORMED AT 3 YEARS DEMONSTRATED MODERATE TO SEVERE, 50-80%, MID PROXIMAL IN-STENT STENOSIS. AN ABI PERFORMED ON THE SAME DAY WAS MILDLY ABNORMAL AT 0.95 IMPRESSION: NO IMAGING OF THE COMPLAINT EVENT WAS PROVIDED HOWEVER THE ULTRASOUND PERFORMED A YEAR PRIOR TO THE COMPLAINT EVENT DEMONSTRATED A MODERATE TO SEVERE IN-STENOSIS IN THE MID PROXIMAL STENTED SEGMENT. WHETHER THIS LESION WAS IN THE STUDY STENTS CANNOT BE DETERMINED BECAUSE A THIRD STENT NOT MENTIONED IN THE COMPLAINT REPORT WAS IMPLANTED AFTER AND PROXIMAL TO THE STUDY STENTS. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT¿S ANATOMY WERE OBSERVED. THE ARTERIES OVERALL WERE SMALL AND INFLOW AND OUTFLOW LIMITED. THE INFLOW LIMITATION WAS AT LEAST PARTIALLY ADDRESSED BY THE THIRD STENT. SINGLE VESSEL RUNOFF INTO THE FOOT WAS NOT PRESENT. FLOW TO THE FOOT WAS PROVIDED BY PERONEAL ARTERY RECONSTITUTION OF THE DORSAL PEDIS ARTERY. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. THE ATHEROSCLEROSIS WAS DIFFUSE WITH ONLY SHORT ISOLATED SEGMENTS OF NORMAL CALIBER VESSEL IMAGED. ADDITIONALLY THE PATIENT WAS OF ADVANCED AGE AND REPORTEDLY CONTINUING TO ABUSE TOBACCO. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE MAY HAVE BEEN OBSERVED. THE MORE PROXIMAL OF THE TWO STUDY STENTS HAVE DEVELOPED A MODERATE TO SEVERE IN-STENT STENOSIS FROM NEOINTIMAL HYPERPLASIA HOWEVER THIS CANNOT BE DEFINITELY CONFIRMED BECAUSE THE STENOSIS COULD ALSO BE IN THE ADJACENT THIRD STENT.¿ NO IMAGING OF THE COMPLAINT EVENT WAS PROVIDED, THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE IMAGING REVIEW, NO IMAGING OF THE COMPLAINT EVENT WAS PROVIDED, HOWEVER, THE ULTRASOUND A YEAR PRIOR TO THE COMPLAINT EVENT DEMONSTRATED A MODERATE TO SEVERE IN-STENOSIS IN THE MID PROXIMAL STENTED SEGMENT. WHETHER THIS LESION WAS IN THE STUDY STENTS CANNOT BE DETERMINED BECAUSE THE STENOSIS COULD ALSO BE IN THE ADJACENT THIRD STENT. THE THIRD STENT, NOT MENTIONED IN THE COMPLAINT REPORT, WAS IMPLANTED AFTER AND PROXIMAL TO THE STUDY STENTS. A NEW COMPLAINT FILE WILL BE CREATED TO CAPTURE THE THIRD STENT WHICH WAS IMPLANTED AT THE 1 YEAR FOLLOW UP. IT CAN BE NOTED THAT THE ARTERIES OVERALL WERE SMALL AND INFLOW AND OUTFLOW WAS LIMITED. ADDITIONALLY THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES MELLITUS TYPE I, HYPERCHOLESTEROLEMIA, ADVANCED AGO AND CONTINUED TO ABUSE TOBACCO. THE PATIENT ALSO EXPERIENCED WORSENING CLAUDICATION. IT CAN BE NOTED THAT THIS SYMPTOM 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. BASED ON THE ABOVE, 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. 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 EVENTS 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, THE FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON INFORMATION TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES WITH LOT NUMBER C910446. ACCORDING TO INFORMATION PROVIDED THE PATIENT UNDERWENT A SECONDARY INTERVENTION. TREATMENT INCLUDED ATHERECTOMY AND BALLOON ANGIOPLASTY. NO ADVERSE EFFECTS WERE REPORTED FOR THIS PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
PMA/510(K)#: P100022/S001. THE ZIV6-35-125-6-80-PTX STENT OF LOT NUMBER C910446 WAS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. FROM AVAILABLE INFORMATION, IT IS KNOWN THAT THE PATIENT HAD PRE-EXISTING CONDITIONS INCLUDING CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES MELLITUS TYPE I, HYPERCHOLESTEROLEMIA, AND IS A CURRENT SMOKER. THE PATIENT ALSO EXPERIENCED WORSENING CLAUDICATION. IT CAN BE NOTED THAT THIS SYMPTOM INDICATES PROGRESSION OF PERIPHERAL ARTERY DISEASE AND CAN ALSO BE ASSOCIATED WITH THE RESTENOSIS PROCESS. IN ADDITION PRE-INTERVENTIONAL ANGIOGRAPHY REVEALED THAT THE STUDY LESION WAS 50-99% STENOSED. 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 COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER A DEFINITIVE CAUSE OF THIS EVENT 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 EVENTS 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, THE FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON INFORMATION TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES WITH LOT NUMBER C910446. ACCORDING TO INFORMATION PROVIDED THE PATIENT UNDERWENT A SECONDARY INTERVENTION. TREATMENT INCLUDED ATHERECTOMY AND BALLOON ANGIOPLASTY. NO ADVERSE EFFECTS WERE REPORTED FOR THIS PATIENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. NOTE AS A RESULT OF THIS IMAGE REVIEW A THIRD STENT WAS IDENTIFIED AS A SUSPECT DEVICE. REFERENCE REPORT # 3001845648-2016-00193. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: (B)(6), PT. (B)(6), WORSENED CLAUDICATION PROBABLY RELATED TO THE STUDY PRODUCT/PROCEDURE. ON (B)(6) 2013, TWO 6.0 MM X 80 MM (LOT # C919314/ C910446) AND ZILVER PTX V STUDY STENTS WERE PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. PRE-DILATATION WAS NOT PERFORMED. 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 5.0 MM X 150 MM DILATATION BALLOON AT 14 ATM FOR 17 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 6.0 MM. THE POST-PROCEDURAL ABIS WERE NOT PERFORMED. ON (B)(6) 2013 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING BRILINTA. ON (B)(6) 2014 THE PATIENT STOPPED TAKING BRILINTA FOR AN UNKNOWN REASON. ON (B)(6) 2014 THE PATIENT RESUMED BRILINTA. ON (B)(6) 2016 THE PATIENT EXPERIENCED WORSENING CLAUDICATION/REST PAIN. THE RIGHT LEG RUTHERFORD CLASSIFICATION WAS FOUR. THE LEFT LEG WAS NOT ASSESSED. THE PRE-INTERVENTION ABIS WERE NOT PERFORMED. PRE-INTERVENTIONAL ANGIOGRAPHY REVEALED THAT THE STUDY LESION WAS 50-99% STENOSED. CLINICAL SIGNS AND SYMPTOMS INCLUDED WORSENING CLAUDICATION. ON (B)(6) 2016 TREATMENT INCLUDED ATHERECTOMY AND BALLOON ANGIOPLASTY AND RESULTED IN A RESIDUAL STENOSIS OF < 50%. THE ATTENDING PHYSICIAN DETERMINED THAT THE WORSENING CLAUDICATION/REST PAIN WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND THE PROCEDURE [SITE QUERIED]. AS 2 ZILVER PTX DEVICES ARE REPORTED AS INVOLVED IN THIS EVENT A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE REPORT # 3001845648-2016-00168.
(B)(6), WORSENED CLAUDICATION PROBABLY RELATED TO THE STUDY PRODUCT/PROCEDURE. ON (B)(6) 2013, TWO 6.0 MM X 80 MM (LOT # C919314/ C910446) AND ZILVER® PTX® V STUDY STENTS WERE PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. PRE-DILATATION WAS NOT PERFORMED. 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 5.0 MM X 150 MM DILATATION BALLOON AT 14 ATM FOR 17 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 6.0 MM. THE POST-PROCEDURAL ABIS WERE NOT PERFORMED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING BRILINTA®. ON (B)(6) 2014, THE PATIENT STOPPED TAKING BRILINTA® FOR AN UNKNOWN REASON. ON (B)(6) 2014, THE PATIENT RESUMED BRILINTA®. ON (B)(6) 2016 THE PATIENT EXPERIENCED WORSENING CLAUDICATION/REST PAIN. THE RIGHT LEG RUTHERFORD CLASSIFICATION WAS FOUR. THE LEFT LEG WAS NOT ASSESSED. THE PRE-INTERVENTION ABIS WERE NOT PERFORMED. PRE-INTERVENTIONAL ANGIOGRAPHY REVEALED THAT THE STUDY LESION WAS 50-99% STENOSED. CLINICAL SIGNS AND SYMPTOMS INCLUDED WORSENING CLAUDICATION. ON (B)(6) 2016 TREATMENT INCLUDED ATHERECTOMY AND BALLOON ANGIOPLASTY AND RESULTED IN A RESIDUAL STENOSIS OF < 50%. THE ATTENDING PHYSICIAN DETERMINED THAT THE WORSENING CLAUDICATION/REST PAIN WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND THE PROCEDURE [SITE QUERIED]. AS 2 ZILVER PTX DEVICES ARE REPORTED AS INVOLVED IN THIS EVENT A SEPARATE REPORT HAS BEEN SUBMITTED FOR EACH SUSPECT DEVICE. REFERENCE REPORT # 3001845648-2016-00168.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421964 | 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 | 81 YR | Required Intervention |