ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2018-00288
- Event Type
- Malfunction
- Date Received
- June 27, 2018
- Date of Event
- May 24, 2018
- Report Date
- August 24, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002518541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
510(K) NUMBER; N/A. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. 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: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510 (K) NUMBER: N/A. 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 ZFV6-125-10-6.0 DEVICE DELIVERY SYSTEM OF LOT NUMBER C1458061 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. THERE ARE TWO FAILURE MODES AND COMPLAINT FILES LINKED TO THIS OCCURRENCE AND DEVICE. REFER TO COMPLAINT FILE (B)(4) FOR DETAILS OF THE SECOND FAILURE MODE (UNABLE TO WITHDRAW OVER WIRE GUIDE). FROM CUSTOMER TESTIMONY, THE TARGET LOCATION FOR THE COMPLAINT DEVICE WAS THE THORACIC ARTERY, TO TREAT AN ANEURYSM. THE CUSTOMER REPORTED THAT THEY HAVE IMAGES OF THE PROCEDURE, BUT NOT OF THE PLACEMENT OF THE STENT. THE DEVICE STENT WAS MISLAID DURING TRANSPORT. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28TH JUNE 2018. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE WAS RETURNED WITHOUT THE STENT OR THE RED SAFETY TAB. THE DEVICE WAS RETURNED WITH A 0.035¿ DIAMETER WIRE GUIDE STILL LOADED IN THE DEVICE LUMEN. SEVERAL BENDS AND KINKS WERE FOUND IN THE FLEXOR. THE HANDLE CANNULA WAS BENT, WHICH THE ENGINEERS SUGGESTED COULD HAVE OCCURRED DURING TRANSPORT. IT WAS NOT POSSIBLE TO REMOVE THE WIRE GUIDE FROM THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF THE DEVICE IN A NON-INDICATED LOCATION. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE DEVICE WAS USED IN THE THORACIC ARTERY, TO TREAT AN ANEURYSM. THE USE IN A NON INDICATED LOCATION COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT ELONGATION. HOWEVER, AS THE STENT AND THE IMAGES OF THE PROCEDURE ARE NOT AVAILABLE AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS PER THE PRODUCT INSTRUCTIONS FOR USE: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY¿¿ DOCUMENT REVIEW: COMPONENT SUPPLIED BY EXTERNAL SUPPLIERS ARE SUBJECT TO INCOMING QC INSPECTION. A REVIEW OF INCOMING QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZILVER FLEX 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, 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 C1458061. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WAS DETERMINED TO BE LOW (CATEGORY IIA). 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.
(B)(4). COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
P050017/S006. 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 PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
THE STENT LOOKED AROUND 8CM LONG INSIDE THE SHEATH UNDER FLUORO WHILE IT SHOULD HAVE BEEN 6CM LONG. PROBABLY THE PROXIMAL END OF THE STENT WAS 2CM AWAY FROM THE PROXIMAL MARK OF THE DELIVERY SYSTEM BUT THE REALITY IS THAT WE WERE NOT SURE WHETHER THE STENT WAS LONGER THAN STATED IN THE PACKAGING. THE FACT IS THAT STARTING FROM THE PROXIMAL MARK OF THE SYSTEM, THE DISTAL PART OF THE STENT WAS LANDING TWO FAR AWAY INSIDE THE TARGET VESSEL AND THEY COULD NOT RISK PLACING SUCH A LONG STENT. IN ADDITION, WHEN THEY DECIDED NOT TO DEPLOY IT AND REMOVE THE ENTIRE SYSTEM OUT OF THE PATIENT, THE DEVICE WOULD NOT COME OUT OVER THE WIRE, LOOKS LIKE IT WAS STUCK, SO THEY REMOVED THE TWO THINGS TOGETHER AS A BLOCK AND THEREFORE LOST POSITION OF THE WIRE.
THE STENT LOOKED AROUND 8CM LONG INSIDE THE SHEATH UNDER FLUORO WHILE IT SHOULD HAVE BEEN 6CM LONG. PROBABLY THE PROXIMAL END OF THE STENT WAS 2CM AWAY FROM THE PROXIMAL MARK OF THE DELIVERY SYSTEM BUT THE REALITY IS THAT WE WERE NOT SURE WHETHER THE STENT WAS LONGER THAN STATED IN THE PACKAGING. THE FACT IS THAT STARTING FROM THE PROXIMAL MARK OF THE SYSTEM, THE DISTAL PART OF THE STENT WAS LANDING TWO FAR AWAY INSIDE THE TARGET VESSEL AND THEY COULD NOT RISK PLACING SUCH A LONG STENT. IN ADDITION, WHEN THEY DECIDED NOT TO DEPLOY IT AND REMOVE THE ENTIRE SYSTEM OUT OF THE PATIENT, THE DEVICE WOULD NOT COME OUT OVER THE WIRE -LOOKS LIKE IT WAS STUCK- SO THEY REMOVED THE TWO THINGS TOGETHER AS A BLOCK AND THEREFORE LOST POSITION OF THE WIRE.
THE STENT LOOKED AROUND 8CM LONG INSIDE THE SHEATH UNDER FLUORO WHILE IT SHOULD HAVE BEEN 6CM LONG. PROBABLY THE PROXIMAL END OF THE STENT WAS 2CM AWAY FROM THE PROXIMAL MARK OF THE DELIVERY SYSTEM BUT THE REALITY IS THAT WE WERE NOT SURE WHETHER THE STENT WAS LONGER THAN STATED IN THE PACKAGING. THE FACT IS THAT STARTING FROM THE PROXIMAL MARK OF THE SYSTEM, THE DISTAL PART OF THE STENT WAS LANDING TWO FAR AWAY INSIDE THE TARGET VESSEL AND THEY COULD NOT RISK PLACING SUCH A LONG STENT. IN ADDITION, WHEN THEY DECIDED NOT TO DEPLOY IT AND REMOVE THE ENTIRE SYSTEM OUT OF THE PATIENT, THE DEVICE WOULD NOT COME OUT OVER THE WIRE -LOOKS LIKE IT WAS STUCK- SO THEY REMOVED THE TWO THINGS TOGETHER AS A BLOCK AND THEREFORE LOST POSITION OF THE WIRE.
THE STENT LOOKED AROUND 8 CM LONG INSIDE THE SHEATH UNDER FLUORO WHILE IT SHOULD HAVE BEEN 6 CM LONG. PROBABLY THE PROXIMAL END OF THE STENT WAS 2 CM AWAY FROM THE PROXIMAL MARK OF THE DELIVERY SYSTEM BUT THE REALITY IS THAT WE WERE NOT SURE WHETHER THE STENT WAS LONGER THAN STATED IN THE PACKAGING. THE FACT IS THAT STARTING FROM THE PROXIMAL MARK OF THE SYSTEM, THE DISTAL PART OF THE STENT WAS LANDING TWO FAR AWAY INSIDE THE TARGET VESSEL AND THEY COULD NOT RISK PLACING SUCH A LONG STENT. IN ADDITION, WHEN THEY DECIDED NOT TO DEPLOY IT AND REMOVE THE ENTIRE SYSTEM OUT OF THE PATIENT, THE DEVICE WOULD NOT COME OUT OVER THE WIRE -LOOKS LIKE IT WAS STUCK- SO THEY REMOVED THE TWO THINGS TOGETHER AS A BLOCK AND THEREFORE LOST POSITION OF THE WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484425 | ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1458061 | 10827002518541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |