ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2023-00186
- Event Type
- Injury
- Date Received
- March 28, 2023
- Date of Event
- February 21, 2023
- Report Date
- May 17, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # P200023. THIS FILE IS RELATED TO (B)(4). (EMDR REF.-3001845648-2023-00282) , (B)(4). (EMDR REF.-3001845648-2023-00283), (B)(4). (EMDR REF.-3001845648-2023-00284) AND (B)(4).(EMDR REF.-3001845648-2023-00261) AND WILL CAPTURE ¿FRACTURED STENT¿. DEVICE EVALUATION: THE ZVT7-35-120-16-100 DEVICE OF LOT NUMBER C1766826 OR C1799437 INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. TWO STENTS WERE USED DURING THIS PROCEDURE WITH ONE FRACTURING. BOTH LOT NUMBERS WERE GIVEN AS THE USER WASNT SURE WHICH LOT NUMBER RELATED TO THE FRACTURED STENT AS THEY DIDN'T NOTE WHICH ONE WAS PLACED PROXIMALLY. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF BOTH MANUFACTURING RECORDS FOR LOT NUMBER C1766826 AND C1799437 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR EITHER LOT NUMBER WORK ORDERS. INSTRUCTIONS FOR USE/LABEL: THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT SHOULD BE NOTED THAT IFU LISTS STENT STRUCT FRACTURE AS A POTENTIAL ADVERSE EVENT. 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: 1. THE COMPLAINT OF STENT FRACTURE IS CONFIRMED. THE FRACTURE WAS ASSOCIATED THE SUPERIOR END OF A STRETCHED AND DISORDERED ZVT-7 STENT SEGMENT SPANNING WHAT LIKELY WAS A MAY THURNER LESION. 2. THE FRACTURE LIKELY INVOLVED THE STENT PROJECTION INTO THE IVC. BECAUSE OF THE LARGER IVC DIAMETER, THIS PORTION OF THE STENT CAN BE FRACTURED OR WEAKENED BY OVERDILATION DURING POST STENT ANGIOPLASTY. 3. STENT ELEMENT DISORDER COMMONLY OCCURS AT IMPLANTATION AND IS MITIGATED BY A PRE-IMPLANTATION ANGIOPLASTY DIAMETER AT OR WITHIN A FEW MILLIMETRES OF THE STENT DESIGN DIAMETER. STENT STRETCHING INVOLVING THE SUPERIOR END MAYBE A RESULT OF TRACTION AT IMPLANTATION, POST IMPLANTATION ANGIOPLASTY, OR PHYSICAL MOTION OF THE VEIN AND ITS SURROUNDINGS OVER TIME. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE OF THE FRACTURE COULD BE THE EXCESSIVE PRESSURE OR STRESS PLACED ON THE STENT WHICH COULD HAVE WEAKENED THE STENT LEADING TO THE FRACTURE. THE PHYSICAL ACTIVITIES OF A 17 YEAR OLD MALE MAY HAVE CAUSED/CONTRIBUTED TOWARDS STRESS PLACED ON THE STENT WHICH COULD HAVE CAUSED/CONTRIBUTED TO THE STENT FRACTURE. ALSO THE STENT PROJECTION INTO THE IVC COULD HAVE CONTRIBUTED. BECAUSE OF THE LARGER DIAMETER, THIS PORTION OF THE STENT CAN BE FRACTURED OR WEAKENED BY OVERDILATION DURING POST STENT ANGIOPLASTY. IT COULD HAVE ALSO BEEN CAUSED BY THE STENT STRETCHING WHICH MAY HAVE BEEN AS A RESULT OF TRACTION AT IMPLANTATION, POST IMPLANTATION ANGIOPLASTY OR THE PHYSICAL MOTION OF THE VEIN AND ITS SURROUNDINGS OVER TIME. FURTHER INFORMATION REGARDING WHETHER THE PATIENT WAS ADEQUATELY ANTICOAGULATED WAS REQUESTED 3 TIMES. SHOULD THIS INFORMATION BECOME AVAILABLE AT A LATER STAGE, THE FILE CAN BE REASSESSED ACCORDINGLY. CONFIRMATION OF COMPLAINT THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGES. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THEY MET WITH A PHYSICIAN WHO SHARED SOME IMAGES OF A PREVIOUS ZILVER VENA PLACED THAT HAS NOW FRACTURED. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RETURNED DUE TO RE-THROMBOSING AND THE DOCTOR PLACED AN ADDITIONAL STENT IN THE PROXIMAL PIECE THAT WAS FRACTURED. INVESTIGATION FINDINGS CONCLUDE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE PRESSURE OR STRESS PLACED ON THE STENT WHICH COULD HAVE WEAKENED THE STENT LEADING TO THE FRACTURE WHICH MAY HAVE BEEN AS A RESULT OF TRACTION AT IMPLANTATION, POST IMPLANTATION ANGIOPLASTY OR THE PHYSICAL MOTION OF THE VEIN AND ITS SURROUNDINGS OVER TIME. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P200023. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE THE IMAGE REVIEW CONDUCTED ON 07-APR-2023.
PER EMAIL: I MET WITH A PHYSICIAN WHO SHARED WITH ME SOME IMAGES OF A PREVIOUS ZILVER VENA PLACED THAT HAS NOW FRACTURED. THE PATIENT RETURNED DUE TO RE-THROMBOSING AND THE DOCTOR PLACED AN ADDITIONAL STENT IN THE PROXIMAL PIECE THAT WAS FRACTURED. TWO STENTS WERE PLACED THAT DAY AND ARE LISTED BELOW. ACCOUNT: (B)(6). G57454: (B)(6). G57454: (B)(6). ORIGINAL CASE DATE WAS 1/21/2022 PATIENT OUTCOME : "DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? PATIENT HAD ANOTHER DVT." THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 22MAR2023. SG 22MAR2023: DID BOTH LOT # C1766826 & C1799437 FRACTURE, OR JUST ONE OF THEM? WE DON¿T KNOW WHICH STENT WAS PLACED PROXIMALLY TO IDENTIFY WHICH ONE IS FRACTURE. CAN YOU PROVIDE ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PRE-EXISTING CONDITIONS)? 17 YEAR OLD MALE, MAY THUNER, PRIOR DVTS. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE DEVICE USED PERCUTANEOUSLY? YES. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? POP, PATIENT WAS PRONE. WAS THE ACCESS SITE JUGULAR OR FEMORAL? N/A, JUGULAR, FEMORAL OTHER. IF OTHER, PLEASE SPECIFY: POP, PATIENT WAS PRONE. WHAT DISEASE PATHOLOGY WAS BEING TREATED? MAY THURNER, ACUTE OR CHRONIC OBSTRUCTION, RESTENOSIS, OTHER? IF OTHER, PLEASE SPECIFY: MAY THURNER WAS THE LESION APPROACHED VIA CONTRALATERAL OR IPSILATERAL? N/A, CONTRALATERAL, IPSILATERAL WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES. WHAT WAS THE TARGET LOCATION FOR THE STENT? OSTIUM OF COMMON ILIAC. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 12 FR SHEATH FOR PENUMBRA DEVICE WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? MINIMAL. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? YES. DID THE USER PUSH THE HUB DURING DEPLOYMENT? NO. DID THE USER REMOVE SLACK IN THE DELIVERY SYSTEM BEFORE DEPLOYMENT, PER IFU? YES. WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? YES. WAS THE STENT FULLY DEPLOYED IN THE PATIENT? YES. WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT? YES. WAS POST DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES. WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? TWICE AFTER THE STENT, THE PATIENT HAD DVTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13057 | ZILVER VENA VENOUS SELF-EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male | Required Intervention |