ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2018-00354
- Event Type
- Malfunction
- Date Received
- August 9, 2018
- Date of Event
- July 11, 2018
- Report Date
- August 9, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- UDI-DI
- 10827002385181
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
PMA/510(K) # : P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # : P100022/S014. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION THE ZISV6-35-125-8-80-PTX DEVICE OF LOT NUMBER C1381068 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE TARGET LOCATION FOR THE COMPLAINT DEVICE WAS AN INTRA FISTULA IN THE LEFT ARM CEPHALIC VEIN. THE DEVICE WAS ADVANCED OVER A HYDROPHILIC STIFF WIRE GUIDE OF 0.035¿ DIAMETER. THE DEVICE WAS FLUSHED PRIOR TO USE. THE PATIENT ANATOMY WAS NOT SEVERELY CALCIFIED OR TORTUOUS. THE ENTIRE STENT WAS DEPLOYED IN THE PATIENT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IS THE COMPLAINT CONFIRMED? YES IMPLANTATION OF THE STENT, SHORTENED TO 48MM, IS CONFIRMED. THIS LIKELY WAS THE RESULT OF A COMBINATION OF THE FOLLOWING THREE CIRCUMSTANCES. FIRST, SINCE THE SUPPORT SHEATH WOULD HAVE BEEN OUTSIDE THE PATIENT, THE RETRACTION SHEATH WOULD HAVE TENDED TO PULL THE DELIVERY SYSTEM INTO THE PATIENT, CAUSING THE STENT TO DEPLOY IN A CONCERTINAED FASHION. SECOND, DIALYSIS FISTULA OCCLUSIONS TEND TO BE HIGHLY IRREGULAR FIBROTIC LESIONS, PARTICULARLY AFTER ANGIOPLASTY, THAT HAVE A GREATER TENDENCY TO EXTRACT THE STENT. THIRD, THE UPPER ARM PARTICULARLY IN A LARGE PATIENT ANGLES DOWNWARD ENOUGH TO CAUSE FORESHORTENING WHEN THE X-RAY TUBE IS IN THE STANDARD ANTERIOR/POSTERIOR PROJECTION. THIS TYPICALLY IS NOT A PROBLEM AND THEREFORE USUALLY NOT COMPENSATED FOR BY ADDITIONAL TUBE ANGULATION. FORESHORTENING AND THE BEGINNINGS OF CONCERTINAED DEPLOYMENT WOULD APPEAR SIMILAR. BECAUSE SOME FORESHORTENING WOULD HAVE BEEN NORMAL, THE BEGINNINGS OF CONCERTINAED DEPLOYMENT WOULD HAVE ALSO APPEARED NORMAL. COUNTERACTION OF CONCERTINAED DEPLOYMENT WITH DELIVERY SYSTEM TENSIONING WOULD HAVE BEEN DELAYED UNTIL TOO LATE. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT'S ANATOMY: NONE, OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE DISEASE STATE: NONE, OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE: NONE, OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: NONE, OTHER (AS REQUESTED IN COMPLAINT REVIEW INTAKE FORM): NONE. FINDINGS: 1.THREE ANGIOGRAPHIC IMAGES FROM A LEFT UPPER ARM DIALYSIS FISTULAGRAM AND INTERVENTION PHOTOGRAPHED FROM A MONITOR ARE PROVIDED WITH THE COMPLAINT REPORT. 2.THE FIRST IMAGE DEMONSTRATES A 6F SHORT SHEATH IN A CEPHALIC VEIN FISTULA DIRECTED CENTRALLY. A SMALL AMOUNT OF CONTRAST FILLS A CEPHALIC VEIN BRANCH JUST UPSTREAM A CEPHALIC VEIN OCCLUSION. 3.THE SECOND IMAGE FROM A FISTULAGRAM PERFORMED THROUGH THE SHEATH PROXIMAL TO THE OCCLUSION DEMONSTRATES THE OCCLUSION AS WELL AS COLLATERAL CEPHALIC VEIN BRANCHES. COLLATERALS PARTIALLY BACKFILLED THE CEPHALIC VEIN DOWNSTREAM THE OCCLUSION. THIS DELINEATED THAT THE OCCLUSION WAS APPROXIMATELY THREE TO FOUR CENTIMETERS IN LENGTH. 4.THE THIRD IMAGE DEMONSTRATES THE 80MM LONG STENT IMPLANTED TO A LENGTH OF 48MM. THE MID STENT IS SEVERELY CONCERTINAED. THE STENT WAS DEPLOYED IN THE EXPECTED LOCATION OF THE OCCLUSION. NO RESIDUAL STENOSIS FROM EXTERNAL CONSTRAINT OF THE STENT WAS PRESENT. 5.THE CIRCUMFERENCE OF THE PATIENT'S ARM INDICATES A HIGH BODY MASS INDEX PATIENT. IMPRESSION: IMPLANTATION OF THE STENT, SHORTENED TO 48MM, IS CONFIRMED. THIS LIKELY WAS THE RESULT OF A COMBINATION OF THE FOLLOWING THREE CIRCUMSTANCES. FIRST, SINCE THE SUPPORT SHEATH WOULD HAVE BEEN OUTSIDE THE PATIENT, THE RETRACTION SHEATH WOULD HAVE TENDED TO PULL THE DELIVERY SYSTEM INTO THE PATIENT, CAUSING THE STENT TO DEPLOY IN A CONCERTINAED FASHION. SECOND, DIALYSIS FISTULA OCCLUSIONS TEND TO BE HIGHLY IRREGULAR FIBROTIC LESIONS, PARTICULARLY AFTER ANGIOPLASTY, THAT HAVE A GREATER TENDENCY TO EXTRACT THE STENT. THIRD, THE UPPER ARM PARTICULARLY IN A LARGE PATIENT ANGLES DOWNWARD ENOUGH TO CAUSE FORESHORTENING WHEN THE X-RAY TUBE IS IN THE STANDARD ANTERIOR/POSTERIOR PROJECTION. THIS TYPICALLY IS NOT A PROBLEM AND THEREFORE USUALLY NOT COMPENSATED FOR BY ADDITIONAL TUBE ANGULATION. FORESHORTENING AND THE BEGINNINGS OF CONCERTINAED DEPLOYMENT WOULD APPEAR SIMILAR. BECAUSE SOME FORESHORTENING WOULD HAVE BEEN NORMAL, THE BEGINNINGS OF CONCERTINAED DEPLOYMENT WOULD HAVE ALSO APPEARED NORMAL. COUNTERACTION OF CONCERTINAED DEPLOYMENT WITH DELIVERY SYSTEM TENSIONING WOULD HAVE BEEN DELAYED UNTIL TOO LATE. THE COMPLAINT IS CONFIRMED AS IMPLANTATION OF THE STENT, SHORTENED TO 48MM, IS CONFIRMED IN THE IMAGING REVIEW. A LIKELY ROOT CAUSE FOR THIS COMPLAINT IS USER ERROR/OFF LABEL USE. AS PER THE IMAGE REVIEW, THE SHORTENING OF THE STENT WAS THE LIKELY RESULT OF THE LOCATION OF THE SUPPORT SHEATH BEING OUTSIDE THE PATIENT¿S BODY, THE PRESENCE OF DIALYSIS FISTULA AND LARGER PATIENT ANATOMY. THE SUPPORT SHEATH WOULD HAVE BEEN LOCATED OUTSIDE OF THE PATIENT RESULTING IN THE RETRACTION SHEATH PULLING THE DELIVERY SYSTEM INTO THE PATIENT RESULTING IN THE STENT DEPLOYING IN A CONCERTAINED FASHION. DIALYSIS FISTULA OCCLUSIONS TEND TO BE HIGHLY IRREGULAR FIBROTIC LESIONS, PARTICULARLY AFTER ANGIOPLASTY, THAT HAVE A GREATER TENDENCY TO EXTRACT THE STENT. THE UPPER ARM, PARTICULARLY IN A LARGE PATIENTS, ANGLES DOWNWARD ENOUGH TO CAUSE FORESHORTENING WHEN THE X-RAY TUBE IS IN THE STANDARD ANTERIOR/POSTERIOR PROJECTION. FORESHORTENING AND THE BEGINNINGS OF CONCERTINAED DEPLOYMENT WOULD APPEAR SIMILAR. BECAUSE SOME FORESHORTENING WOULD HAVE BEEN NORMAL, THE BEGINNINGS OF CONCERTINAED DEPLOYMENT WOULD HAVE ALSO APPEARED NORMAL. COUNTERACTION OF CONCERTINAED DEPLOYMENT WITH DELIVERY SYSTEM TENSIONING WOULD HAVE BEEN DELAYED UNTIL TOO LATE. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE NOTED THAT AS PER THE PRODUCT INSTRUCTION FOR USE (IFU0118-3): ¿THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO OR RESTENOTIC SYMPTOMATIC LESIONS IN NATIVE VASCULAR DISEASE OF THE ABOVE THE KNEE FEMOROPOPLITEAL ARTERIES¿¿ DOCUMENT REVIEW 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 (C1381068) 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 C1381068. SUMMARY THE COMPLAINT IS CONFIRMED AS IMPLANTATION OF THE STENT, SHORTENED TO 48MM, IS CONFIRMED IN THE IMAGING REVIEW. THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE STENT WAS FULLY DEPLOYED IN THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMB-WHEEL MALFUNCTIONS DURING DEPLOYMENT¿ AND "STENT COMPRESSION DURING DEPLOYMENT". AS REPORTED TO CUSTOMER RELATIONS, "FISTULA STENOSIS. PATIENT HAD REOCCURRING STENOSIS AND NOT RESPONDING TO ANGIOPLASTY. PHYSICIAN REQUESTED STENTS FOR BETTER RESULTS. THE STENT DEPLOYED WITH DIFFICULTY. WHILE THEY WERE MOVING THE THUMB-WHEEL, THEY COULD NOT SEE THE STENT BEING DEPLOYED. THE STENT FINALLY DEPLOYED AFTER SEVERAL ACTIONS ON THE THUMB-WHEEL. ONCE DEPLOYED, A SEGMENT IN THE STENT WAS NOT FULLY STRETCHED OUT".
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿THUMBWHEEL MALFUNCTIONS DURING DEPLOYMENT¿ AND "STENT COMPRESSION DURING DEPLOYMENT". AS REPORTED TO CUSTOMER RELATIONS, "FISTULA STENOSIS. PATIENT HAD REOCCURRING STENOSIS AND NOT RESPONDING TO ANGIOPLASTY. PHYSICIAN REQUESTED STENTS FOR BETTER RESULTS. THE STENT DEPLOYED WITH DIFFICULTY. WHILE THEY WERE MOVING THE THUMBWHEEL, THEY COULD NOT SEE THE STENT BEING DEPLOYED. THE STENT FINALLY DEPLOYED AFTER SEVERAL ACTIONS ON THE THUMBWHEEL. ONCE DEPLOYED, A SEGMENT IN THE STENT WAS NOT FULLY STRETCHED OUT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609843 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | G38518 | C1381068 | 10827002385181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |