ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2018-00372
- Event Type
- Malfunction
- Date Received
- August 9, 2018
- Date of Event
- July 13, 2018
- Report Date
- May 16, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002519050
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K) # : 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 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) # : P050017/S006. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT "ZFV STENT TIP WAS CURVED, SO (B)(6) COULDN'T APPROACH THE TARGET LESION (SMA) HE NOTICED THE CURVED TIP UNDER THE FLUOROSCOPY. " DEVICE EVALUATION THIS INVESTIGATION ADDRESSES THE ZFV6-80-8-8.0 DEVICE OF LOT NUMBER C1324978. FOR INVESTIGATION DETAILS OF THE SECOND DEVICE, PLEASE REFER TO (B)(4). THE ZFV6-80-8-8.0 DEVICE OF LOT NUMBER C1324978 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. FROM CUSTOMER TESTIMONY IT IS KNOWN THAT THE DEVICE WAS USED IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE CUSTOMER REPORTED THAT THE CURVE IN THE DISTAL WHITE TIP WAS ONLY NOTICED UNDER FLUOROSCOPY DURING THE PROCEDURE. THE DEVICE WAS FLUSHED THROUGH BOTH FLUSHING PORTS. A 0.035¿ TERUMO HYDROPHILIC WIRE GUIDE WAS USED WITH THE DEVICE. THE PATIENT¿S ANATOMY WAS CALCIFIED AND THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE DEVICE THROUGH THE LESION. THE PHYSICIAN ATTEMPTED TO PASS THE TARGET LESION SEVERAL TIMES BUT WAS UNSUCCESSFUL. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 16 AUGUST 2018. THE DEVICE WAS FLUSHED WITH NO MAJOR ISSUES DESPITE THE PRESENCE OF CONGEALED BLOOD. A 0.035¿ WIRE GUIDE WAS ADVANCED THROUGH THE DEVICE WITH NO ISSUES. THE STENT WAS DEPLOYED WITH NO RESISTANCE, WAS UNDAMAGED AND MEASURED 8.0 CM IN LENGTH. CURVATURE IN THE WHITE TIP WAS NOT OBSERVED DURING THE LAB EVALUATION HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT ENCOUNTER RESISTANCE DURING ADVANCEMENT. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE ROOT CAUSES FOR THIS COMPLAINT COULD INCLUDE USE OF THE DEVICE IN AN UNINTENDED AREA (SMA) (OFF-LABEL USE) AND/OR CALCIFIED PATIENT ANATOMY. IT IS POSSIBLE THAT THE CALCIFIED ANATOMY OR USE IN AN UNINTENDED AREA COULD HAVE CAUSED OR CONTRIBUTED TO THE RESISTANCE FELT BY THE PHYSICIAN. SINCE THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE SEVERAL TIMES, IT IS POSSIBLE THAT MULTIPLE ATTEMPTS TO ADVANCE THE DEVICE TO THE TARGET LOCATION CAUSED THE FISH MOUTH DAMAGE ON THE WHITE TIP AS OBSERVED DURING THE LAB EVALUATION. A FOLLOW UP QUESTION WAS ASKED AFTER THE LAB EVALUATION TO DETERMINE WHAT PART OF THE DEVICE THE CUSTOMER FOUND TO BE BENT. IT WAS CONFIRMED THAT THE CUSTOMER FELT THE ZFV STENT CATHETER DISTAL TIP WAS BENT. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT AND THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY¿. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZFV6 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1324978) 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 C1324978. SUMMARY CURVATURE IN THE WHITE TIP WAS NOT OBSERVED DURING THE LAB EVALUATION HOWEVER, THERE WAS ¿FISH MOUTH¿ DAMAGE ON THE TIP. THIS DAMAGE SUGGESTS DIFFICULTIES DURING ADVANCEMENT AND THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED. THE RISK WAS DETERMINED TO BE LOW RISK/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.
PMA/510(K) # : P050017/S006. PROBLEM STATEMENT "ZFV STENT TIP WAS CURVED, SO DR. JUNG COULDN'T APPROACH THE TARGET LESION (SMA) HE NOTICED THE CURVED TIP UNDER THE FLUOROSCOPY. " DEVICE EVALUATION THIS INVESTIGATION ADDRESSES THE ZFV6-80-8-8.0 DEVICE OF LOT NUMBER C1324978. FOR INVESTIGATION DETAILS OF THE SECOND DEVICE, PLEASE REFER TO (B)(4). THE ZFV6-80-8-8.0 DEVICE OF LOT NUMBER C1324978 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. FROM CUSTOMER TESTIMONY IT IS KNOWN THAT THE DEVICE WAS USED IN THE SUPERIOR MESENTERIC ARTERY (SMA) . THE CUSTOMER REPORTED THAT THE CURVE IN THE DISTAL WHITE TIP WAS ONLY NOTICED UNDER FLUOROSCOPY DURING THE PROCEDURE. THE DEVICE WAS FLUSHED THROUGH BOTH FLUSHING PORTS. A 0.035¿ TERUMO HYDROPHILIC WIRE GUIDE WAS USED WITH THE DEVICE. THE PATIENT¿S ANATOMY WAS CALCIFIED AND THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE DEVICE THROUGH THE LESION. THE PHYSICIAN ATTEMPTED TO PASS THE TARGET LESION SEVERAL TIMES BUT WAS UNSUCCESSFUL. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 16 AUGUST 2018. THE DEVICE WAS FLUSHED WITH NO MAJOR ISSUES DESPITE THE PRESENCE OF CONGEALED BLOOD. A 0.035¿ WIRE GUIDE WAS ADVANCED THROUGH THE DEVICE WITH NO ISSUES. THE STENT WAS DEPLOYED WITH NO RESISTANCE, WAS UNDAMAGED AND MEASURED 8.0 CM IN LENGTH . CURVATURE IN THE WHITE TIP WAS NOT OBSERVED DURING THE LAB EVALUATION HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT ENCOUNTER RESISTANCE DURING ADVANCEMENT. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE ROOT CAUSES FOR THIS COMPLAINT COULD INCLUDE USE OF THE DEVICE IN AN UNINTENDED AREA (SMA) (OFF-LABEL USE) AND/OR CALCIFIED PATIENT ANATOMY. IT IS POSSIBLE THAT THE CALCIFIED ANATOMY OR USE IN AN UNINTENDED AREA COULD HAVE CAUSED OR CONTRIBUTED TO THE RESISTANCE FELT BY THE PHYSICIAN. SINCE THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE SEVERAL TIMES, IT IS POSSIBLE THAT MULTIPLE ATTEMPTS TO ADVANCE THE DEVICE TO THE TARGET LOCATION CAUSED THE FISH MOUTH DAMAGE ON THE WHITE TIP AS OBSERVED DURING THE LAB EVALUATION. A FOLLOW UP QUESTION WAS ASKED AFTER THE LAB EVALUATION TO DETERMINE WHAT PART OF THE DEVICE THE CUSTOMER FOUND TO BE BENT. IT WAS CONFIRMED THAT THE CUSTOMER FELT THE ZFV STENT CATHETER DISTAL TIP WAS BENT. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT AND THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU0058-3) STATES THE FOLLOWING: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY¿. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZFV6 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1324978) 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 C1324978. SUMMARY CURVATURE IN THE WHITE TIP WAS NOT OBSERVED DURING THE LAB EVALUATION HOWEVER, THERE WAS ¿FISH MOUTH¿ DAMAGE ON THE TIP. THIS DAMAGE SUGGESTS DIFFICULTIES DURING ADVANCEMENT AND THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED. THE RISK WAS DETERMINED TO BE LOW RISK/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.
THIS REPORT IS BEING SUBMITTED BASED ON OVERALL RISK WHICH HAS BEEN ASSESSED AS CATEGORY IIB (MODERATE). "ZFV STENT TIP WAS CURVED, SO DR. (B)(6) COULDN'T APPROACH THE TARGET LESION (SMA). HE NOTICED THE CURVED TIP UNDER THE FLUOROSCOPY.. "
"ZFV STENT TIP WAS CURVED, SO DR. (B)(6) COULDN'T APPROACH THE TARGET LESION(SMA). HE NOTICED THE CURVED TIP UNDER THE FLOROSCOPY.. "
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO UPDATE TO PRODUCT LOT # FIELD IT WAS AT CF1137806, IT HAS BE CHANGED TO CI324978.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608442 | ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | C1324978 | 10827002519050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |