ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2022-00342
- Event Type
- Injury
- Date Received
- June 3, 2022
- Date of Event
- October 19, 2021
- Report Date
- September 30, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. ZILVER VENA PRODUCT CODE: QAN; 510K#: P200023.
ZILVER VENA PRODUCT CODE: QAN. 510K#: P200023. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO PR 362913 (3001845648-2022-00339) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. REFERENCE ¿MORRIS LITERATURE COMPLAINTS.MSG ( SOURCE DOC).MSG¿. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZVT7 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE, (IFU0047). IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE INFORM THE USER OF POTENTIAL ADVERSE EVENTS, SUCH AS 'STENT MALOPPOSITION' WHICH MAY OCCUR WITH USE OF THE ZILVER VENA DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. IT IS POSSIBLE THAT DIFFICULT PATIENT ANATOMY MAY HAVE CAUSED OR CONTRIBUTED TO UNEVEN EXPANSION OF THE STENT. IT MAY BE NOTED THAT AS PER INSTRUCTIONS FOR USE, STENT MALAPPOSITION IS LISTED AS A COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, IT IS KNOWN THAT THE PATIENT REQUIRED THE IMPLANTATION OF A SECOND STENT TO RE-LINE THE LESION, WITHIN THE SAME OPERATING PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. ZILVER VENA PRODUCT CODE: QAN. 510K#: P200023.
MORRIS ET AL 2021 ¿ ¿PERFORMANCE OF OPEN AND CLOSED CELL LASER CUT NITINOL STENTS FOR THE TREATMENT OF CHRONIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION IN PATIENTS TREATED AT A SINGLE CENTRE¿. WHEN STENTING ACROSS THE INGUINAL LIGAMENT WAS REQUIRED, AN APPROPRIATE DISTAL LANDING ZONE ABOVE THE CONFLUENCE OF THE FEMORAL VEIN (FV) AND PROFUNDA FEMORAL VEIN (PFV) WAS IDENTIFIED USING IVUS, NO STENTS WERE EXTENDED INTO THE FV OR PFV. SELECTED PATIENTS WITH EXTENSIVE COMMON FEMORAL AND INFLOW DISEASE HAD AN ENDOPHLEBECTOMY AND TEMPORARY ARTERIOVENOUS FISTULA CREATED TO IMPROVE FLOW THROUGH THE STENT SYSTEM. INADEQUATE EXPANSION OF THE STENT DETECTED BY INTRAVASCULAR ULTRASOUND (IVUS) WAS OBSERVED DURING THE INDEX PROCEDURE FOR FIVE PATIENTS (FOUR OC, ONE CC), AND CORRECTED WITH RE-LINING INTRA-OPERATIVELY.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO UPDATED A, E AND F CODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2035000 | ZILVER VENA VENOUS SELF-EXPANDING STENT | Stent, iliac vein | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |