ZILVER VENA VENOUS SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2024-00236
- Event Type
- Injury
- Date Received
- May 27, 2024
- Date of Event
- November 28, 2023
- Report Date
- September 10, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- QAN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # P200023 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # P200023. THIS FILE WAS OPENED IN RESPONSE TO THE ATTACHED LITERATURE ARTICLE, ALY 2023 - ILIOCAVAL AND ILIOFEMORAL VENOUS STENTING FOR OBSTRUCTION SECONDARY TO TUMOR COMPRESSION: SINGLE CENTER EXPERIENCE. THIS FILE WILL CAPTURE OF LOSS OF PATENCY FOR 02 DEVICES. THIS FILE IS RELATED TO (B)(4). DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE ZILVER VENA DEVICES OR PHOTOGRAPHIC EVIDENCE OF THE DEVICES 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. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: THERE IS NO EVIDENCE THAT THE USER DID NOT FOLLOW THE IFU/LABEL. IT SHOULD BE NOTED THAT RESTENOSIS IS LISTED AS A KNOWN POTENTIAL ADVERSE EFFECT IN THE DEVICE IFU. IFU0047 STATES THAT ¿POTENTIAL ADVERSE EVENTS THAT MAY OCCUR, INCLUDE BUT ARE NOT LIMITED TO: ABRUPT STENT CLOSURE, ALLERGIC REACTION TO ANTICOAGULANT AND/OR ANTITHROMBOTIC THERAPY OR CONTRAST MEDIUM, ALLERGIC REACTION TO NITINOL, ARRYTHMIA, ARTERIOVENOUS FISTULA, DEATH, EMBOLISM, FEVER, HEMATOMA/HEMORRHAGE AT THE ACCESS SITE, HYPERSENSITIVITY REACTIONS, HYPERTENSION, HYPOTENSION, NAUSEA OR SYMPTOMS OF A VASOVAGAL RESPONSE, INFECTION/ABSCESS FORMATION AT ACCESS SITE, INTIMAL INJURY/DISSECTION, MYOCARDIAL INFARCTION, PSEUDOANEURYSM FORMATION, PULMONARY EMBOLISM, RENAL FAILURE, RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN, RETINAL, RETROPERITONEAL, GASTROINTESTINAL, OR GENITOURINARY BLEEDING ASSOCIATED WITH ANTICOAGULANT THERAPY, SEPTICEMIA/BACTEREMIA, SPASM, STENT MALPOSITION, STENT MIGRATION, STENT STRUT FRACTURE, STROKE, TISSUE NECROSIS, VESSEL PERFORATION/RUPTURE, WORSENED PAIN.¿ IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE OF PATIENT PRE-EXISTING CONDITIONS. ACCORDING TO THE FILE, PATIENT PRE-EXISTING CONDITIONS INCLUDED CAVAL, ILIAC OR ILIOFEMORAL VENOUS OBSTRUCTION RELATED TO MALIGNANT PELVIABDOMINAL MASSES, WITH NEW OR INCREASED LOWER EXTREMITY SWELLING WAS DETERMINED. THE PROGRESSION OF THESE PRE-EXISTING CONDITIONS COULD HAVE POTENTIALLY LED TO THE COMPRESSION OR NARROWING OF THE VESSEL WHICH COULD HAVE EXERTED PRESSURE ON THE STENT, LEADING THE STENT TO POSSIBLY BECOMING DISTORTED OR IMPAIRED OR WEAKENED DUE TO THIS PRESSURE AND THUS NOT BEING ABLE TO MAINTAIN PATENCY OF THE VESSEL. THIS IS SUPPORTED BY MEDICAL ADVISOR INPUT STENT RESTENOSIS IS DEFINED AS THE NARROWING OR BLOCKAGE OF A PREVIOUSLY IMPLANTED STENT IN A BLOOD VESSEL. THIS CONDITION CAN OCCUR AFTER A SUCCESSFUL PROCEDURE, WHERE A STENT IS PLACED TO KEEP THE VESSEL OPEN AND RESTORE BLOOD FLOW. HOWEVER, IN SOME CASES, THE INNER LINING OF THE BLOOD VESSEL MAY GROW BACK OVER THE STENT, LEADING TO THE STENT TO BECOME NARROWED OR COMPLETELY BLOCKED AGAIN. THIS CAN OCCUR DUE TO PROGRESSION OF A PATIENT'S PRE-EXISTING CONDITION. RESTENOSIS CAN BE CAUSED BY INJURY TO THE VESSEL (E.G., DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS TO (OR AMPLIFIES) THE RESTENOSIS PROCESS. STENT OCCLUSION OCCURS WHEN AN IMPLANTED STENT BECOMES BLOCKED DUE TO THE FORMATION OF A BLOOD CLOT WITHIN OR AROUND THE STENT. THIS COULD LEAD TO THE ARTERIES BECOMING NARROWED. THESE NARROWED ARTERIES COULD LEAD TO PRESSURE BEING EXERTED ON THE STENT AS THE NARROWING PROGRESSES. THIS CAN ALSO OCCUR DUE TO PROGRESSION OF A PATIENT'S PRE-EXISTING CONDITION. IT SHOULD ALSO BE NOTED THAT OCCLUSION AND RESTENOSIS ARE COMMON ADVERSE EVENTS OF ENDOVASCULAR PROCEDURES AND RESTENOSIS IS LISTED AS KNOWN POTENTIAL ADVERSE EVENTS WITHIN THE IFU. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION: FOR ALL COMPLAINTS A RECOMMENDED ACTION WILL BE TO CONTINUE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED IN RESPONSE TO THE ATTACHED LITERATURE ARTICLE, ALY 2023 - ILIOCAVAL AND ILIOFEMORAL VENOUS STENTING FOR OBSTRUCTION SECONDARY TO TUMOR COMPRESSION: SINGLE CENTER EXPERIENCE. CONFIRMED QUANTITY OF 02 DEVICES USED. NO INFORMATION ON TREATMENT OR PATIENT OUTCOME IS LISTED IN THE PAPER. CLINICAL INPUT DEEMED THAT A SEVERITY OF 1 BE ASSIGNED AS NO TREATMENT WAS MENTIONED IN THE ARTICLE, THIS FILE WAS CONSERVATIVELY OPENED TO CAPTURE THE LOSS OF PATENCY THAT DID NOT REQUIRE TARGET LESION REVASCULARIZATION (TLR). MEDICAL ADVISOR INPUT WAS REQUESTED, AS PER INPUT RECEIVED ¿LOSS OF PATENCY DOES NOT ALWAYS GUARANTEE A REINTERVENTION I.E., TLR TREATMENT. TREATMENT OR NO TREATMENT WAS NOT MENTIONED IN THE ARTICLE¿. A POSSIBLE ROOT CAUSE OF PATIENT PRE- EXISTING CONDITIONS OF CAVAL, ILIAC OR ILIOFEMORAL VENOUS OBSTRUCTION RELATED TO MALIGNANT PELVIABDOMINAL MASSES WAS DETERMINED.
DESCRIPTION OF EVENT: ALY, 2023 ¿ ILIOCAVAL AND ILIOFEMORAL VENOUS STENTING FOR OBSTRUCTION SECONDARY TO TUMOR COMPRESSION: SINGLE CENTER EXPERIENCE VENOGRAPHY WAS PERFORMED TO DELINEATE THE ANATOMY OF THE OBSTRUCTION (FIG. 1,2). THE OBSTRUCTION WAS CROSSED USING A COMBINATION OF 4 FR/5 FR CATHETER AND 0.035 CROSSING WIRE. WHEN DVT WAS PRESENT PHARMACO-MECHANICAL OR PURE MECHANICAL THROMBECTOMY WAS PERFORMED ACCORDING TO THE OPERATOR¿S PREFERENCE. IN ACUTE DVT CASES WHERE THE THROMBUS WAS NOT CLEARED BY THROMBECTOMY, AN INFUSION CATHETER WAS PLACED, AND OVERNIGHT THROMBOLYSIS WAS PERFORMED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED IN SOME CASES TO BETTER DELINEATE THE EXTENSION AND DEGREE OF THE OBSTRUCTION. IVC, ILIOCAVAL AND/OR ILIOFEMORAL STENT PLACEMENT WAS THEN PERFORMED. MULTIPLE STENT TYPES WERE USED DEPENDING ON OPERATOR PREFERENCE INCLUDING WALL STENT (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA), VENOVO (BARD/BECTON, DICKINSON AND COMPANY, TEMPE, ARIZONA, USA), VICI (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA), SMART (CORDIS CORP, FREMONT, CA, USA), ZILVERVENA (COOK, BLOOMINGTON, IN, USA) AND/OR VIABAHN STENT GRAFT (WL GORE AND ASSOCIATES, FLAGSTAFF, AZ, USA). POST-STENTING BALLOON DILATATION WAS PERFORMED WHEN NECESSARY TO DILATE THE STENTS TO TARGET DIAMETER. LOSS OF PATENCY: PRIMARY PATENCY OF THE PLACED STENTS AT 1, 3 AND 6 MONTHS WAS 93%, 81% AND 69% RESPECTIVELY (FIG. 4). 7% LOSS OF PATENCY AT 1 MONTH 19% LOSS OF PATENCY AT 3 MONTH 31% LOSS OF PATENCY AT 6 MONTH PATIENT OUTCOME: PER LITERATURE COMPLAINT FORM: NO INFORMATION IN ARTICLE PATIENT/EVENT INFO - NOTES: 37 PATIENTS AVERAGE AGE 63 19 MALE: 18 FEMALE.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-SEP-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330720 | ZILVER VENA VENOUS SELF-EXPANDING STENT | STENT, ILIAC VEIN | QAN | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |