ZILVER PTX 35 DRUG-ELUTING STENT
Report
- Report Number
- 3001845648-2019-00092
- Event Type
- Injury
- Date Received
- March 7, 2019
- Date of Event
- January 31, 2019
- Report Date
- April 4, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
510(K) NUMBER: 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). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: 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)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ZISV6-35-125-7-120-PTX DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28TH MARCH 2019. THE DEVICE WAS DISMANTLED ON RECEIPT AND CRINKLING WAS OBSERVED ON THE STENT RETRACTION SHEATH (SRS). THE STENT WAS PARTIALLY DEPLOYED AND FRACTURED. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS COULD NOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZISV6-35-125-7-120-PTX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZISV6-35-125-7-120-PTX OF UNKNOWN LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT SHOULD BE NOTED THAT THE IFU STATES THE FOLLOWING: ¿IF RESISTANCE IS MET DURING ADVANCEMENT OF THE DELIVERY SYSTEM, DO NOT FORCE PASSAGE. REMOVE THE DELIVERY SYSTEM AND REPLACE WITH A NEW DEVICE.¿ ¿DO NOT USE EXCESSIVE FORCE TO DEPLOY THE STENT. IF EXCESSIVE RESISTANCE IS FELT WHEN BEGINNING DEPLOYMENT, REMOVE THE DELIVERY SYSTEM WITHOUT DEPLOYING THE STENT AND REPLACE WITH A NEW DEVICE.¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. IT IS POSSIBLE THAT DIFFICULT PATIENT ANATOMY COULD HAVE CAUSED AND/OR CONTRIBUTED TO RESISTANCE DURING ADVANCEMENT AND/OR DEPLOYMENT RESULTING IN HIGH DEPLOYMENT FORCES BEING EXERTED ON THE DEVICE. THE HIGH FORCE ON THE SRS WOULD HAVE CONTRIBUTED TO THE RETRACTION WIRE SEPARATING FROM THE SRS DURING DEPLOYMENT. IT IS POSSIBLE THAT THE DIFFICULT PATIENT ANATOMY ALSO CAUSED AND/OR CONTRIBUTED TO THE PARTIALLY DEPLOYED STENT BECOMING FRACTURED ON REMOVAL OF THE DEVICE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: 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.
AS REPORTED TO CUSTOMER RELATIONS, "THE DOCTOR WAS DEPLOYING THE DEVICE IN THE SFA AND AS HE WAS ROLLING THE THUMBWHEEL BACK, SOMETHING HAPPENED AND THE THUMBWHEEL KEPT ROLLING BUT THE STENT WAS NOT DEPLOYING. IT WAS ABOUT HALF DEPLOYED (HALF IN THE SYSTEM AND HALF IN THE BODY). AT THIS POINT, THE HANDLE WAS TAKEN APART IN AN ATTEMPT TO DEPLOY THE STENT AND THIS DID NOT WORK. THE PHYSICIAN HAD TO TAKE THE STENT AND THE DELIVERY SYSTEM OUT OF THE BODY AND WHEN THE PHYSICIAN DID THIS, A SMALL PIECE OF THE STENT BROKE OFF AND REMAINED IN THE PATIENTS LEG. AT THIS POINT, THE PHYSICIAN OPENED UP A NEW STENT AND DEPLOYED IT IN THE PIECE OF THE STENT THAT BROKE OFF (THIS IS WHERE HE WANTED TO DEPLOY THE STENT IN THE FIRST PLACE). IN DEPLOYING THIS SECOND STENT WHERE THE PHYSICIAN WANTED TO, HE WAS ABLE TO PIN THE BROKE OFF PIECE OF STENT IN THE VESSEL. AT THIS POINT, THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN WAS HAPPY WITH THE RESULT." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE AS THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. PATIENT REQUIRED INTERVENTION. ALSO REPORTABLE UNDER THE FOLLOWING PRECEDENCE: ¿ RETRACTION WIRE SEPARATES FROM STENT RETRACTION SHEATH ¿ DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT ¿ STENT FRACTURE
AS REPORTED TO CUSTOMER RELATIONS, "THE DOCTOR WAS DEPLOYING THE DEVICE IN THE SFA AND AS HE WAS ROLLING THE THUMBWHEEL BACK, SOMETHING HAPPENED AND THE THUMBWHEEL KEPT ROLLING BUT THE STENT WAS NOT DEPLOYING. IT WAS ABOUT HALF DEPLOYED (HALF IN THE SYSTEM AND HALF IN THE BODY). AT THIS POINT, THE HANDLE WAS TAKEN APART IN AN ATTEMPT TO DEPLOY THE STENT AND THIS DID NOT WORK. THE PHYSICIAN HAD TO TAKE THE STENT AND THE DELIVERY SYSTEM OUT OF THE BODY AND WHEN THE PHYSICIAN DID THIS, A SMALL PIECE OF THE STENT BROKE OFF AND REMAINED IN THE PATIENTS LEG. AT THIS POINT, THE PHYSICIAN OPENED UP A NEW STENT AND DEPLOYED IT IN THE PIECE OF THE STENT THAT BROKE OFF (THIS IS WHERE HE WANTED TO DEPLOY THE STENT IN THE FIRST PLACE). IN DEPLOYING THIS SECOND STENT WHERE THE PHYSICIAN WANTED TO, HE WAS ABLE TO PIN THE BROKE OFF PIECE OF STENT IN THE VESSEL. AT THIS POINT, THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN WAS HAPPY WITH THE RESULT." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE AS THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. PATIENT REQUIRED INTERVENTION. ALSO REPORTABLE UNDER THE FOLLOWING PRECEDENCE: RETRACTION WIRE SEPARATES FROM STENT RETRACTION SHEATH, DEPLOYMENT DIFFICULTY RESULTING IN PARTIAL STENT DEPLOYMENT, STENT FRACTURE.
AS REPORTED TO CUSTOMER RELATIONS, "THE DOCTOR WAS DEPLOYING THE DEVICE IN THE SFA AND AS HE WAS ROLLING THE THUMBWHEEL BACK, SOMETHING HAPPENED AND THE THUMBWHEEL KEPT ROLLING BUT THE STENT WAS NOT DEPLOYING. IT WAS ABOUT HALF DEPLOYED (HALF IN THE SYSTEM AND HALF IN THE BODY). AT THIS POINT, THE HANDLE WAS TAKEN APART IN AN ATTEMPT TO DEPLOY THE STENT AND THIS DID NOT WORK. THE PHYSICIAN HAD TO TAKE THE STENT AND THE DELIVERY SYSTEM OUT OF THE BODY AND WHEN THE PHYSICIAN DID THIS, A SMALL PIECE OF THE STENT BROKE OFF AND REMAINED IN THE PATIENTS LEG. AT THIS POINT, THE PHYSICIAN OPENED UP A NEW STENT AND DEPLOYED IT IN THE PIECE OF THE STENT THAT BROKE OFF (THIS IS WHERE HE WANTED TO DEPLOY THE STENT IN THE FIRST PLACE). IN DEPLOYING THIS SECOND STENT WHERE THE PHYSICIAN WANTED TO, HE WAS ABLE TO PIN THE BROKE OFF PIECE OF STENT IN THE VESSEL. AT THIS POINT, THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN WAS HAPPY WITH THE RESULT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191796 | ZILVER PTX 35 DRUG-ELUTING STENT | NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |