ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2021-00691
- Event Type
- Injury
- Date Received
- September 23, 2021
- Date of Event
- August 26, 2021
- Report Date
- June 29, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- UDI-DI
- 10827002574479
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) #: P200023. PRODUCT CODE: QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #: P200023. PRODUCT CODE: QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510K: P200023. DEVICE EVALUATION: THE ZVT7-35-80-16-60 DEVICE OF LOT NUMBER C1792883 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZVT7-35-80-16-60 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 ZVT7-35-120-14-6.0OF LOT NUMBER C1792883 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 C1792883. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091-7) STATES THE FOLLOWING: ¿THE ZILVER VENA VENOUS STENT IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC VENOUS OUTFLOW OBSTRUCTION¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IT IS KNOWN THAT THE DEVICE WAS USED FOR STENTING OF THE IVC. THIS IS OFF LABEL USE. IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IMPRESSION: 1. THE COMPLAINT OF ZVT7-35-80-16-60 FRACTURE DURING SNARE REMOVAL IS CONFIRMED. AN IMAGE OF THE REMOVED FRACTURED STENT WAS PROVIDED. 2. THE THREE PROVIDED IMAGES WERE CONSISTENT WITH THE COMPLAINT REPORT NARRATIVE. THE ZVT7-35-80-16-60 HAD BEEN IMPLANTED IN A THE DISTAL IVC. IT THEN MIGRATED TO THE JUXTA RENAL AND INTRAHEPATIC IVC. ITS REPOSITIONING OR REMOVAL WAS NECESSARY AS IT WOULD HAVE COVERED THE RENAL VEINS. THE ZVT7-35-80-16-60 WAS LIKELY DISPLACED BY THE CATHETER INSERTED TO REMOVE A CELECT FILTER LEG FROM A RIGHT INFERIOR ACCESSORY HEPATIC VEIN. 3. THE ZVT7-35-80-16-60 WAS LIKELY NOT OVERSIZED TO THE IVC. 4. CIV STENTS WERE NOT INSERTED INTO THE ZVT7-35-80-16-60. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED, IT IS KNOWN THAT THE SENT WAS PLACED IN THE IVC. PER CLINICAL INPUT, THIS IS OFF- LABEL USE AND THE MAIN CONTRIBUTING FACTOR TO STENT MIGRATION. THE MIGRATION OF THE STENT MEANT THAT THE USER NEEDED TO REMOVE THE STENT TO PREVENT FURTHER MIGRATION OF THE STENT. THIS REMOVAL OF THE STENT RESULTED IN STENT FRACTURE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE FRACTURED PIECES OF THE STENT WERE RETRIEVED FROM THE PATIENT WITHIN THE SAME OPERATING PROCEDURE. 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.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED ON 30-DEC-2021. CONFIRMATION RECEIVED FROM CLINICAL THAT USE OF THE VENA STENT IN THE IVC IS OFF-LABEL, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO UPDATE THE IMDRF A CODE.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF IMAGING REVIEW ON 13-MAY-2022: IMAGING REVIEW COMPLETED ON 13-MAY-2022: IMPRESSION 1. THE COMPLAINT OF ZVT7-35-80-16-60 FRACTURE DURING SNARE REMOVAL IS CONFIRMED. AN IMAGE OF THE REMOVED FRACTURED STENT WAS PROVIDED. 2. THE THREE PROVIDED IMAGES WERE CONSISTENT WITH THE COMPLAINT REPORT NARRATIVE. THE ZVT7-35-80-16-60 HAD BEEN IMPLANTED IN A THE DISTAL IVC. IT THEN MIGRATED TO THE JUXTA RENAL AND INTRAHEPATIC IVC. ITS REPOSITIONING OR REMOVAL WAS NECESSARY AS IT WOULD HAVE COVERED THE RENAL VEINS. THE ZVT7-35-80-16-60 WAS LIKELY DISPLACED BY THE CATHETER INSERTED TO REMOVE A CELECT FILTER LEG FROM A RIGHT INFERIOR ACCESSORY HEPATIC VEIN. 3. THE ZVT7-35-80-16-60 WAS LIKELY NOT OVERSIZED TO THE IVC. 4. CIV STENTS WERE NOT INSERTED INTO THE ZVT7-35-80-16-60.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 29-JUN-2022
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: P200023. PRODUCT CODE: QAN.
AS INSTRUCTED FROM CIRL "ACCESS WAS RIGHT AND LEFT FEMORAL VEIN, AND JUGULAR VEIN WITH 18FR X 35CM COOK SHEATHS IN BOTH THE IJ & RIGHT FEMORAL VEIN. THERE WAS AN 8 FR SHEATH IN THE LEFT FEMORAL VEIN. THE PATIENT HAD A 10-YEAR-OLD CELET IVC FILTER IN THAT WAS REMOVED PRIOR TO PLACING STENTS. ONCE REMOVED, THE PHYSICIAN USES IVUS TO MEASURE THE IVC WHICH MEASURED A 14.2MM DIAMETER. HE DECIDED TO PLACE A 16X60 ZILVER VENA IN THE IVC RIGHT AT THE CONFLUENCE FROM THE RIGHT FEMORAL VEIN. THEN FOLLOWED THAT STENT WITH TWO 14X140 STENTS IN THE COMMON ILIAC VEINS. THESE WERE ALL PLACED FROM THE FEMORAL VEIN ACCESS. THE PHYSICIAN USED IVUS AGAIN TO CONFIRM PLACEMENT. HE THEN HAD TO RETRIEVE A PIECE OF FILTER THAT HAD BROKEN OFF IN THE LIVER DURING THE IVC FILTER RETRIEVAL AND REALIZED THE ZILVER VENA STENT THAT WAS PLACED IN THE IVC HAD MIGRATED UP HIGHER IN THE IVC. (B)(4) HE DID MENTION IT COULD HAVE BEEN DRAGGED UP FROM THE CATHETER HE WAS USING TO RETRIEVE THE PIECE OF IVC FILTER. THE PHYSICIAN TRIED PUSHING THE STENT DOWN WITH A LARGE SNARE THEN DECIDED IT NEEDED TO COME OUT. HE USED THE LARGE SNARE FROM BOTH ABOVE AND BELOW THROUGH THE 18FR SHEATHS TO SNARE AND REMOVE THE ZILVER VENA STENT FROM THE PATIENT. THE STENT DID FRACTURE IN 3 PIECES BUT THEY WERE ABLE TO RETRIEVE ALL PIECES OF THE STENT. (B)(4) THE PATIENT DID GREAT, NO ADDITIONAL SURGERIES WERE NEEDED AND THE FINAL IMAGES LOOKED GOOD. I HAVE ATTACHED PICTURES OF THE INITIAL STENTS, THE MIGRATED STENT, THE REMOVED STENT, AND THE FINAL IMAGE." THIS FILE WILL CAPTURE "STENT FRACTURE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1418555 | ZILVER VENA VENOUS SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | G57447 | C1792883 | 10827002574479 |
| 1418556 | ZILVER VENA VENOUS SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | G57447 | C1792883 | 10827002574479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention |