ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2022-00475
- Event Type
- Malfunction
- Date Received
- July 27, 2022
- Date of Event
- January 20, 2022
- Report Date
- October 28, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
POTENTIAL 510K + PRODUCT CODES: ZIV, P050017/S002 AND S003, NIO, ZILVER FLEX, P050017/S006, NIO, ZILVER VENA, P200023, QAN. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO PR 369986 AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. IT IS NOT KNOWN FROM THE JOURNAL ARTICLE WHAT ZILVER STENT WAS USED IN THE STUDY SO THE INVESTIGATION IS BASED ON A ZVT7, AS THE DEVICE WAS IMPLANTED INTO THE VENOUS SYSTEM. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES ¿THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION¿.HERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS HOWEVER, FROM THE ARTICLE IT IS KNOWN THAT THE DEVICE WAS USED IN THE RIGHT TRANSVERSE SINUS. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER TOWNSEND ET AL ¿MAJOR COMPLICATIONS OF DURAL VENOUS SINUS STENTING FOR IDIOPATHIC INTRACRANIAL HYPERTENSION: CASE SERIES AND MANAGEMENT CONSIDERATIONS'. ACCORDING TO THE LITERATURE PAPER, 01 DEATH WAS REPORTED HOWEVER THE DEATH WAS NOT RELATED TO THE USE OF THE DEVICE AS PER CLINICAL INPUT. NO DEVICE RELATED ADVERSE EVENTS WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. PMA/510(K) #: P200023 SECTION D: COMMON NAME - QAN.
TOWNSEND ET AL 2021 ¿ ¿MAJOR COMPLICATIONS OF DURAL VENOUS SINUS STENTING FOR IDIOPATHIC INTRACRANIAL HYPERTENSION: CASE SERIES AND MANAGEMENT CONSIDERATIONS¿. COMPLICATION 4: A PATIENT IN THEIR 50S PRESENTED WITH BLURRED VISION, PAPILLEDEMA, AND ELEVATED OPENING PRESSURE ON LUMBAR PUNCTURE. VENOGRAPHY DEMONSTRATED SEVERE STENOSIS OF THE RIGHT TS WITH SIGNIFICANT PRESSURE GRADIENT. THE PATIENT WAS PLACED ON DUAL ANTIPLATELET THERAPY OF ASPIRIN 325 MG AND CLOPIDOGREL 75 MG DAILY FOR 7 DAYS PRE-PROCEDURE AND UNDERWENT VSS UNDER GENERAL ANESTHESIA. A NEURON 070 GUIDE CATHETER WAS NAVIGATED OVER A BERENSTEIN 5F INSERT INTO THE RIGHT TS, WHERE A ZILVER STENT WAS DEPLOYED ACROSS THE STENOSIS WITHOUT ISSUE. RUNS FROM THE ICA WERE OBTAINED DEMONSTRATING NO COMPLICATIONS, AND THE PATIENT WAS AWOKEN FROM ANESTHESIA WITHOUT INCIDENT. THIS FILE WILL CAPTURE OFF LABEL USE OF THE ZILVER STENT IN THE RIGHT TRANSVERSE SINUS. NO DEVICE RELATED ADVERSE EFFECTS REPORTED.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2022 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722894 | ZILVER VENA VENOUS SELF-EXPANDING STENT | STENT, ILIAC | NIO | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |