ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2023-00483
- Event Type
- Malfunction
- Date Received
- June 21, 2023
- Date of Event
- June 10, 2019
- Report Date
- October 4, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA 510K #P050017/S004. DEVICE EVALUATION. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. THIS FILE WAS CREATED FROM THE ATTACHED LITERATURE ARTICLE ¿AVGERINOS ET AL 2019 - OUTCOMES OF LEFT RENAL VEIN STENTING IN PATIENTS WITH NUTCRACKER SYNDROME¿ AND WAS OPENED TO CAPTURE THE OFF-LABEL USE OF ZILVER VENA STENT FOR LEFT RENAL VEIN (LVR) STENTING IN PATIENTS WITH NUTCRACKER SYNDROME WITH NO ADVERSE EVENTS REPORTED. 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. MANUFACTURING RECORDS. PRIOR TO DISTRIBUTION ALL ZILVER VENA STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. IFU/LABEL REVIEW. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) STATES THE FOLLOWING: ¿THE ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED FOR THE AVAILABLE INFORMATION. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. FROM THE ARTICLE IT IS KNOWN THAT STENTS WERE PLACED IN THE LEFT RENAL VEIN OF PATIENTS IN PATIENTS WITH NUTCRACKER SYNDROME FOR WHICH THIS IS NOT THE INTENDED USE OF THIS DEVICE. PER THE IFU, ZILVER VENA STENTS ARE ONLY INDICATED FOR USE FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION. IT SHOULD BE NOTED THAT, AS THE DEVICE WAS USED OUTSIDE OF ITS VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICES WILL PERFORM OR FUNCTION. AS PER (B)(4), REV006, SECTION 5.3 TABLE 1 - OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. CONFIRMATION OF COMPLAINT. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY. ACCORDING TO THE INITIAL REPORTER, THIS COMPLAINT WAS RAISED FROM LITERATURE ARTICLE ¿AVGERINOS ET AL 2019 - OUTCOMES OF LEFT RENAL VEIN STENTING IN PATIENTS WITH NUTCRACKER SYNDROME¿. THIS COMPLAINT WAS OPENED TO CAPTURE OFF-LABEL USE OF ZILVER VENA STENT FOR LEFT RENAL VEIN (LVR) STENTING IN PATIENTS WITH NUTCRACKER SYNDROME. AS PER IFU0091-8,¿ ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION.¿ CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. ACCORDING TO THE ARTICLE IT IS KNOWN THAT STENTS WERE PLACED IN THE LEFT RENAL VEIN IN PATIENTS WITH NUTCRACKER SYNDROME FOR WHICH THIS IS NOT THE INTENDED USE OF THIS DEVICE. AS PREVIOUSLY MENTIONED THE IFU STATES THAT ZVT7 DEVICES ARE USED TO IMPROVE THE LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA 510K #P050017 S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-OCT-2023.
AVGERINOS ET AL 2019 - OUTCOMES OF LEFT RENAL VEIN STENTING IN PATIENTS WITH NUTCRACKER SYNDROME METHODS: A RETROSPECTIVE CHART REVIEW OF PATIENTS WITH NUTCRACKER SYNDROME (NCS) WHO UNDERWENT LRV STENTING BETWEEN 2010 AND 2018 WAS PERFORMED. END POINTS WERE PERIOPERATIVE ADVERSE OUTCOMES, SYMPTOM RELIEF, AND STENT PATENCY. SYMPTOM RESOLUTION WAS CLASSIFIED AS COMPLETE, PARTIAL, AND NONE ON THE BASIS OF THE INTERPRETATION OF MEDICAL RECORDS ON CLINICAL FOLLOW-UP. STANDARD DESCRIPTIVE STATISTICS AND SURVIVAL ANALYSIS WERE USED. ALL PATIENTS RECEIVED SELF EXPANDING STENTS (MEAN DIAMETER, 12.8 6 1.6 MM), THE SMALLER ONES TYPICALLY PLACED IN THE PREVIOUSLY TRANSPOSED LRV'S. PATIENT 13 A 39 YEAR OLD FEMALE WITH FLANK PAIN, PELVIC VARICOSITIES, WEIGHT LOSS WAS TREATED WITH A 10 X 40 ZILVER STENT THIS COMPLAINT WAS OPENED TO CAPTURE OFF-LABEL USE OF ZILVER VENA STENT FOR LEFT RENAL VEIN (LVR) STENTING. AS PER IFU0091-8,¿ ZILVER VENA VENOUS STENT IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION.¿ NO ADVERSE EFFECTS TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252056 | ZILVER VENA VENOUS SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |