ZILVER 518 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00673
- Event Type
- Malfunction
- Date Received
- September 15, 2021
- Date of Event
- August 17, 2021
- Report Date
- April 1, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002437873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P050017/S002 AND S003. DEVICE EVALUATION: THE ZIV5-18-125-9-60 DEVICE OF LOT NUMBER C1800545 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIV5-18-125-9-60 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 ZIV5-18-125-9-60 OF LOT NUMBER C1800545 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT 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 C1800545. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0043-9) STATES THE FOLLOWING: ¿INTRODUCE THE EXTRA OR ULTRA-STIFF WIRE GUIDE (7.0 AND 6.0 FRENCH [2.3 AND 2.0 MM] SYSTEMS ACCEPT 0.035 INCH [0.89 MM] WIRE GUIDE; 5.0 FRENCH [1.67 MM] SYSTEM ACCEPTS 0.018 INCH [0.46 MM] WIRE GUIDE) THROUGH THE ACCESS CATHETER ACROSS THE DISTAL SEGMENT OF THE TARGET LESION.¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE EVIDENCE FROM THE INVESTIGATION SUGGESTS THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION AVAILABLE IT IS KNOWN THAT A 0.014¿ WIRE GUIDE WAS USED WITH THIS DEVICE DURING THE PROCEDURE. AS PER THE IFU, IT IS RECOMMENDED THAT 0.018-INCH WIRE GUIDE IS USED WITH THE ZIV5-18-125-9-60 DEVICE, WHICH IS A 5.0 FRENCH SYSTEM. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO CONFIRMATION ON 18-OCT-21 THAT USER ERROR OCCURED.
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO CONFIRMATION ON THE (B)(6) 2022 THAT STENT WHICH WAS 'CRINKLED' WAS NOT A CIRL STENT.
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 01-APR-2022.
"AFTER FORMULA STENT WAS PLACED IN THE INTERVENTION LEFT COMMON ILIAC ARTERY THEY ATTEMPTED TO PLACE 9X60 SES STENT AND WOULD NOT CROSS CAUSING FORMULA STENT TO "CRINKLE" AT THE PROXIMAL END. THEY REMOVED THE STENT AND INSERTED THE SHORTER 9X40 STENT WHICH CROSSED, FOLLOWED UP BY 9X80 STENT." PATIENT OUTCOME: DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? - NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? - NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? - NO. ADDITIONAL QUESTIONS: 3.35 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO NO 3.36 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? UNPACKING OR PREPARATION OF THE DEVICE, INSERTION, STENT PLACEMENT, REMOVING THE INTRODUCER. STENT PLACEMENT. 3.37 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6FR 11CM TERUMO SHEATH. 3.38 WHAT WAS THE TARGET LOCATION FOR THE STENT? LEFT COMMON ILIAC. 3.39 WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? N/A, YES, NO. YES 3.40 WAS THE DEVICE USED PERCUTANEOUSLY? N/A,YES,NO. YES 3.41 WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? N/A, YES, NO. YES 3.42 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? N/A, YES, NO. YES 3.43 WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? N/A, YES, NO. N/A 3.44 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? HYDRO ST. 3.45 DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? TORTUOUS, CALCIFIED, 3.46 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO. 3.47 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? YES, 3.48 HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? REMOVED STENT AND INSERTED A LONGER STENT 3.49 WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? IPSILATERAL. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, 3.50 DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? NO. 3.51 WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY? NO. 3.52 WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO. 3.53 WAS THE HANDLE PULLED TOWARDS THE HUB DURING DEPLOYMENT? N/A. 3.54 WAS THE DELIVERY SYSTEM PUSHED DURING DEPLOYMENT? N/A. 3.55 WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? N/A IF NO, PLEASE DETAIL ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT: 3.56 WHAT ARTERY WAS THE STENT PLACED IN? LCIA. 3.57 WAS THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM PRIOR TO REMOVAL OF THE DELIVERY SYSTEM? N/A. 3.58 DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? YES. IF YES, PLEASE SPECIFY: CALCIFIED AND TOURTUOUS. 3.59 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 3.60 WHAT INTERVENTION (IF ANY) WAS REQUIRED? NONE. 3.61 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A. 3.62 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? NO PLEASE SPECIFY IF YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1372366 | ZILVER 518 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | G43787 | C1800545 | 10827002437873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female |