BIOMIMICS 3D VASCULAR STENT SYSTEM
Report
- Report Number
- 3011632150-2021-00019
- Event Type
- Injury
- Date Received
- May 24, 2021
- Date of Event
- April 26, 2021
- Report Date
- October 12, 2023
- Manufacturer
- VERYAN MEDICAL LTD
- Product Code
- NIP
- UDI-DI
- 05391526850176
- PMA / PMN Number
- P180003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS ADVERSE EVENT WAS ORIGINALLY REPORTED AS A THROMBOSIS OF TREATED SEGMENT. THE DETAILS OF THE ADVERSE EVENT HAVE BEEN UPDATED TO REFLECT NEW INFORMATION PROVIDED BY THE CLINICAL SITE ON (B)(6) 2021 STATING THAT THE INTERVENTION INVOLVED A BYPASS IN THE TARGET VESSEL AND PLANNED AMPUTATION OF THE 5TH TOE DUE TO WORSENING OF DISEASE. THE OUTCOME HAS BEEN UPDATED FROM "CONTINUING" TO "RESOLVED/RECOVERED". THE OUTCOMES ASSOCIATED WITH THE ADVERSE EVENT HAVE ALSO BEEN UPDATED TO INCLUDE HOSPITALISATION, REQUIRED INTERVENTION TO PREVENT IMPAIRMENT AND DISABILITY OR PERMANENT DAMAGE. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS.A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND IS A KNOWN POTENTIAL ADVERSE EFFECT OF PERIPHERAL STENTING PROCEDURES. AMPUTATION AND BYPASS SURGERY ARE ALSO LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE DEVICE IDENTIFIER PART OF THE UDI NUMBER HAS BEEN CORRECTED TO (B)(4).
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT(S) OF OCCLUSION, ENDOVASCULAR INTERVENTION OR AMPUTATION AND WORSENING OF PERIPHERAL ARTERIAL DISEASE LEADING TO ADDITIONAL SURGICAL INTERVENTION ARE LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN POTENTIAL ADVERSE EFFECT OF PERIPHERAL STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT(S) OF OCCLUSION, ENDOVASCULAR INTERVENTION OR AMPUTATION AND WORSENING OF PERIPHERAL ARTERIAL DISEASE LEADING TO ADDITIONAL SURGICAL INTERVENTION ARE LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN POTENTIAL ADVERSE EFFECT OF PERIPHERAL STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SECTION B.5. AND G.6. HAVE BEEN UPDATED.
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS WAS IMPLANTED WITH TWO BIOMIMICS-3D STENTS (A 7.0 X 60MM AND A 7.0 X 80MM) ON (B)(6) 2021 TO TREAT A DE NOVO OCCLUSION (100% STENOSIS) WITH A TARGET LESION LENGTH OF 60MM OF THE SFA MIDDLE THIRD TO DISTAL THIRD OF THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WERE CONDUCTED WITH STANDARD BALLOON ANGIOPLASTY/PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. A THROMBOSIS OF TREATED SEGMENT WAS REPORTED TO VERYAN ON (B)(6) 2021. THE SUBJECT HAD AN UNSCHEDULED FOLLOW-UP VISIT WHERE THE THROMBOSIS WAS IDENTIFIED ON ULTRASOUND WITH A DATE OF ONSET (B)(6) 2021. THE EVENT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE AND PROCEDURE. IT WAS REPORTED AS REQUIRING PERCUTANEOUS INTERVENTION AND SURGERY WHICH WAS SCHEDULED FOR FRIDAY (B)(6) 2021. THE INTERVENTION INVOLVED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY, LASER ATHERECTOMY, GRAFT/BYPASS AND A MINOR PLANNED AMPUTATION OF THE 5TH TOE DUE TO WORSENING OF DISEASE/CLINICAL SYMPTOMATOLOGY. THE OUTCOME DESCRIBED AS RESOLVED/RECOVERED. THE DEVICES REMAIN IMPLANTED.
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS (A 7.0 X 60MM AND A 7.0 X 80MM (THIS REPORT))ON (B)(6) 2021 TO TREAT DENOVO LESIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD AND SFA DISTAL THIRD OF THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENTS WERE POST-DILATED WITH PTA. AN OCCLUSION, EARLY (7 - 30 DAYS TREATED VESSEL) WAS IDENTIFIED BY THE SITE ON (B)(6) 2021. THE PATIENT HAD AN UNSCHEDULED FOLLOW-UP VISIT WHERE THE OCCLUSION WAS IDENTIFIED ON ULTRASOUND. THE EVENT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE AND PROCEDURE. THE INTERVENTION INVOLVED A COMPETITOR BARE METAL STENT PLACEMENT, PTA/ STANDARD BALLOON ANGIOPLASTY AND THROMBECTOMY ON (B)(6) 2021. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). AN ADDITIONAL BYPASS PROCEDURE OF THE SFA PROXIMAL THIRD TO DISTAL POPLITEAL WAS REQUIRED ON (B)(6) 2021 AND A FIFTH TOE AMPUTATION DUE TO WORSENING OF DISEASE WAS PERFORMED ON (B)(6) 2021. THE OUTCOME WAS DESCRIBED AS RESOLVED/RECOVERED. THE DEVICES REMAIN IMPLANTED.
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS (A 7.0 X 60MM AND A 7.0 X 80MM (THIS REPORT)) ON (B)(6)2021 TO TREAT DENOVO LESIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD AND SFA DISTAL THIRD OF THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENTS WERE POST-DILATED WITH PTA. AN OCCLUSION, EARLY (7 - 30 DAYS TREATED VESSEL) WAS IDENTIFIED BY THE SITE ON (B)(6) 2021. THE PATIENT HAD A 30-DAY FOLLOW-UP VISIT WHERE THE OCCLUSION WAS IDENTIFIED ON ULTRASOUND. THE EVENT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE AND PROCEDURE. IT WAS TARGET LESION RELATED. THE INTERVENTION INVOLVED A COMPETITOR BARE METAL STENT PLACEMENT, PTA/ STANDARD BALLOON ANGIOPLASTY AND THROMBECTOMY OF THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL SEGMENT ON (B)(6) 2021. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). AN ADDITIONAL BYPASS PROCEDURE OF THE SFA PROXIMAL THIRD TO DISTAL POPLITEAL WAS REQUIRED ON (B)(6) 2021 AND A MINOR UNPLANNED FIFTH TOE AMPUTATION DUE TO WORSENING OF DISEASE WAS PERFORMED ON (B)(6) 2021. THE OUTCOME WAS DESCRIBED AS RESOLVED/RECOVERED. THE DEVICES REMAIN IMPLANTED.
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND IS A KNOWN POTENTIAL ADVERSE EFFECT OF PERIPHERAL STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THIS IS RELATED TO MDR NUMBER: 3011632150-2021-00018. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON 08 APRIL 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS-3D STENTS (A 7.0 X 60MM AND A 7.0 X 80MM) ON 08-APRIL-2021 TO TREAT A DE-NOVO OCCLUSION (100% STENOSIS) WITH A TARGET LESION LENGTH OF 60MM OF THE SFA MIDDLE THIRD TO DISTAL THIRD OF THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WERE CONDUCTED WITH STANDARD BALLOON ANGIOPLASTY/PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. A THROMBOSIS OF TREATED SEGMENT WAS REPORTED TO VERYAN ON (B)(6) 2021. THE SUBJECT HAD AN UNSCHEDULED FOLLOW-UP VISIT WHERE THE THROMBOSIS WAS IDENTIFIED ON ULTRASOUND WITH A DATE OF ONSET (B)(6) 2021. THE EVENT IS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE AND PROCEDURE. IT WAS REPORTED AS REQUIRING PERCUTANEOUS INTERVENTION WHICH WAS SCHEDULED FOR (B)(6) 2021. NO INFORMATION ON THIS INTERVENTION IS AVAILABLE AT THIS POINT. THE OUTCOME DESCRIBED AS CONTINUING. THE DEVICES REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766003 | BIOMIMICS 3D VASCULAR STENT SYSTEM | BIOMIMICS 3D VASCULAR STENT SYSTEM | NIP | VERYAN MEDICAL LTD | 0000052896 | 05391526850176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Hospitalization| S| R | ANTICOAGULANT - WARFARIN| ASPIRIN| ASPIRIN| ELIQUIS| WARFARIN |