ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
Report
- Report Number
- 3001845648-2022-00480
- Event Type
- Injury
- Date Received
- July 27, 2022
- Date of Event
- November 28, 2020
- Report Date
- January 13, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- NIO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. 510K: P050017/S006.
PMA/510(K) # P050017/S006. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510K P050017/S006. 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. IT IS NOT KNOWN FROM THE JOURNAL ARTICLE WHAT ZILVER DEVICE WAS USED IN THE STUDY, THE INVESTIGATION IS BASED ON A ZILVER FLEX DEVICE. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER FLEX 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE IS IFU0058. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. THE JAPANESE PACKAGING INSERT (C-CI1203Y05) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. PATIENT CHARACTERISTICS INCLUDED THE FOLLOWING RISK FACTORS FOR THROMBOSIS; HYPERTENSION, HYPERLIPIDAEMIA, DIABETES MELLITUS, ATRIAL FIBRILLATION AND SMOKING. AS PER MEDICAL ADVISOR INPUT 'AS PER ARTICLE BELOW THEY USED MRI IMAGING TO LOOK AT STENTS FOR PROTRUSIONS WHICH ARE PARTIAL THROMBOSIS THAT MAY OR MAY NOT HAVE BEEN CLINICALLY RELEVANT. SO WOULD FALL UNDER THROMBOSIS BUT LIKELY RATE WILL BE HIGHER THAN SOTA BECAUSE THESE WERE NOT PICKED UP CLINICALLY.' SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER MARUYAMA ET AL ¿PREOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) FOR PREDICTING THROMBOEMBOLIC COMPLICATIONS DURING ENDOVASCULAR TREATMENT FOR ILIAC ARTERY OCCLUSIONS¿. ACCORDING TO THE INITIAL REPORTER, 01 ZILVER STENT WAS USED IN THE STUDY WHICH MAY HAVE CONTRIBUTED TO 01 CASE OF THROMBOSIS REQUIRING BALLOON ANGIOPLASTY AND ADDITIONAL STENTING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
MARUYAMA 2021, ZILVER AND PREOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) FOR PREDICTING THROMBOEMBOLIC COMPLICATIONS DURING ENDOVASCULAR TREATMENT FOR ILIAC ARTERY OCCLUSIONS. ALL PATIENTS RECEIVED ASPIRIN (100 MG/D) AND CLOPIDOGREL (75 MG/D) FOR AT LEAST 7 DAYS BEFORE THE PROCEDURE. ALL PROCEDURES WERE PERFORMED BY AN EXPERIENCED TEAM VIA THE TRANSFEMORAL APPROACH UNDER LOCAL ANESTHESIA USING AN ANGIOGRAPHY SYSTEM (ARTIS ZEE, SIEMENS AG (B)(4)), WITH CONTRAST MEDIA SUCH AS IOPAMIDOL (OIPAROMIN 300; FUJI PHARMACEUTICAL COMPANY (B)(4)) AND IODIXANOL (VISIPAQUE 270; DAIICHI SANKYO (B)(4)). A BOLUS INJECTION OF HEPARIN (3,000 U) WAS ADMINISTERED IMMEDIATELY AFTER SHEATH INSERTION AND CONTINUED AT 1000 U/H THROUGHOUT THE PROCEDURE. AFTER PASSING THE OCCLUSION, IVUS (VISIONS PV 0.014, PHILIPS VOLCANO (B)(4) USA) WAS USED TO CONFIRM CROSSING OF THE GUIDEWIRE IN THE TRUE OR FALSE LUMEN. DIRECT STENT IMPLANTATION WAS PERFORMED USING SMART (CORDIS (B)(4) USA), EPIC, EXPRESS LD (BOSTON SCIENTIFIC (B)(4) USA), LUMINEXX (BARD INC (B)(4) USA), ZILVER (COOK MEDICAL (B)(4) USA), AND OMNILINK (GUIDANT CORP. (B)(4) USA) STENTS. IF RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT, MINIMAL PREDILATION WAS PERFORMED WITH ULTRAVERSE (BARD INC.), SABER (CORDIS), STERLING (BOSTON SCIENTIFIC), AND ADVANCE (COOK MEDICAL) BALLOON CATHETERS TO PASS THE STENT. THE TYPE OF STENT DEPENDED ON THE OPERATORS¿ DISCRETION IN RELATION TO VESSEL DIAMETER AND OCCLUDED LENGTH. POSTDILATATION WITH AN APPROPRIATELY SIZED BALLOON WAS PERFORMED. IVUS WAS PERFORMED REGULARLY BEFORE AND AFTER STENT PLACEMENT. THE IVUS SYSTEM WAS ADVANCED SUFFICIENTLY BEYOND THE TARGET LESION TO EVALUATE PROXIMAL AND DISTAL REFERENCE SITES AND WITHDRAWN MANUALLY. THE EXTENT OF IN-STENT PROTRUSION WAS DEFINED AS FOLLOWS: MINOR, WITHIN 25% OF STENT CROSS-SECTIONAL AREA; MODERATE, BETWEEN 25% AND 50%; AND SEVERE, GREATER THAN 50%. 12 THROMBOEMBOLIC COMPLICATIONS WERE DEFINED AS DISTAL EMBOLIZATION AND ABOVE MODERATE IN-STENT PROTRUSION CONFIRMED BY ANGIOGRAPHY AND IVUS. IF THE OPERATOR DETERMINED INTRAOPERATIVELY THAT THERE WERE THROMBOEMBOLIC COMPLICATIONS, ADDITIONAL TREATMENT WAS PERFORMED REGARDLESS OF SYMPTOMS. AS PER TABLE 1, 2 MODERATE IN-STENT PROTRUSION REQUIRING BALLOON ANGIOPLASTY (2) AND ADDITIONAL STENTING (1). 5 SEVERE IN-STENT PROTRUSION REQUIRING BALLOON ANGIOPLASTY (4) AND ADDITIONAL STENTING (1).
UPDATE TO DESCRIPTION OF EVENT AND BRIEF DESCRIPTION MADE ON 28-NOV-2022 TO HIGHLIGHT THAT QUANTITY CONFIRMED USED IS 1 AND THE COMPLAINT IS CAPTURING THE POSSIBILITY OF MODERATE INSTENT PROTRUSION OCCURRING WITH 1 ZILVER STENT USED. MARUYAMA 2021, ZILVER AND PREOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) FOR PREDICTING THROMBOEMBOLIC COMPLICATIONS DURING ENDOVASCULAR TREATMENT FOR ILIAC ARTERY OCCLUSIONS. ALL PATIENTS RECEIVED ASPIRIN (100 MG/D) AND CLOPIDOGREL (75 MG/D) FOR AT LEAST 7 DAYS BEFORE THE PROCEDURE. ALL PROCEDURES WERE PERFORMED BY AN EXPERIENCED TEAM VIA THE TRANSFEMORAL APPROACH UNDER LOCAL ANESTHESIA USING AN ANGIOGRAPHY SYSTEM (ARTIS ZEE, SIEMENS AG, FORCHHEIM, GERMANY), WITH CONTRAST MEDIA SUCH AS IOPAMIDOL (OIPAROMIN 300; FUJI PHARMACEUTICAL COMPANY, TOYAMA, JAPAN) AND IODIXANOL (VISIPAQUE 270; DAIICHI SANKYO, TOKYO, JAPAN). A BOLUS INJECTION OF HEPARIN (3,000 U) WAS ADMINISTERED IMMEDIATELY AFTER SHEATH INSERTION AND CONTINUED AT 1000 U/H THROUGHOUT THE PROCEDURE. AFTER PASSING THE OCCLUSION, IVUS (VISIONS PV 0.014, PHILIPS VOLCANO, SAN DIEGO, CA, USA) WAS USED TO CONFIRM CROSSING OF THE GUIDEWIRE IN THE TRUE OR FALSE LUMEN. DIRECT STENT IMPLANTATION WAS PERFORMED USING SMART (CORDIS, FREMONT, CA, USA), EPIC, EXPRESS LD (BOSTON SCIENTIFIC, NATICK, MA, USA), LUMINEXX (BARD INC, MURRAY HILL, NJ, USA), ZILVER (COOK MEDICAL, BLOOMINGTON, IN, USA), AND OMNILINK (GUIDANT CORP., SANTA CLARA, CA, USA) STENTS. IF RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT, MINIMAL PREDILATION WAS PERFORMED WITH ULTRAVERSE (BARD INC.), SABER (CORDIS), STERLING (BOSTON SCIENTIFIC), AND ADVANCE (COOK MEDICAL) BALLOON CATHETERS TO PASS THE STENT. THE TYPE OF STENT DEPENDED ON THE OPERATORS¿ DISCRETION IN RELATION TO VESSEL DIAMETER AND OCCLUDED LENGTH. POSTDILATATION WITH AN APPROPRIATELY SIZED BALLOON WAS PERFORMED. IVUS WAS PERFORMED REGULARLY BEFORE AND AFTER STENT PLACEMENT. THE IVUS SYSTEM WAS ADVANCED SUFFICIENTLY BEYOND THE TARGET LESION TO EVALUATE PROXIMAL AND DISTAL REFERENCE SITES AND WITHDRAWN MANUALLY. THE EXTENT OF IN-STENT PROTRUSION WAS DEFINED AS FOLLOWS: MINOR, WITHIN 25% OF STENT CROSS-SECTIONAL AREA; MODERATE, BETWEEN 25% AND 50%; AND SEVERE, GREATER THAN 50%.12 THROMBOEMBOLIC COMPLICATIONS WERE DEFINED AS DISTAL EMBOLIZATION AND ABOVE MODERATE IN-STENT PROTRUSION CONFIRMED BY ANGIOGRAPHY AND IVUS. IF THE OPERATOR DETERMINED INTRAOPERATIVELY THAT THERE WERE THROMBOEMBOLIC COMPLICATIONS, ADDITIONAL TREATMENT WAS PERFORMED REGARDLESS OF SYMPTOMS. AS PER TABLE 1, 2 MODERATE IN-STENT PROTRUSION REQUIRING BALLOON ANGIOPLASTY (2) AND ADDITIONAL STENTING (1). 5 SEVERE IN-STENT PROTRUSION REQUIRING BALLOON ANGIOPLASTY (4) AND ADDITIONAL STENTING (1). FILE CAPTURING THE POSSIBILITY OF IN STENT PROTRUSION WITH THE 1 ZILVER STENT USED IN THIS STUDY WHICH EXPERIENCED A COMPLICATION ALTHOUGH SPECIFIC COMPLICATION NOT SPECIFIED.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13JAN2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723951 | ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT | NIO STENT, ILIAC | NIO | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |