BIOMIMICS 3D VASCULAR STENT SYSTEM
Report
- Report Number
- 3011632150-2022-00027
- Event Type
- Injury
- Date Received
- June 1, 2022
- Date of Event
- April 30, 2021
- Report Date
- December 20, 2022
- Manufacturer
- VERYAN MEDICAL LTD
- Product Code
- NIP
- UDI-DI
- 05391526850404
- PMA / PMN Number
- P180003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS MDR IS RELATED TO 3011632150-2022-00028. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW HAS BEEN PERFORMED OF THE MANUFACTURING CERTIFICATE OF CONFORMANCE ASSOCIATED WITH THIS LOT. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS WHICH COULD BE ASSOCIATED WITH 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 RESTENOSIS IS LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN PATIENT EFFECTS 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.
DATE OF REPORT CORRECTED FROM 04 JUNE 2022 TO 01 JUNE 2022.
THIS MDR IS RELATED TO 3011632150-2022-00028. THIS EVENT OF RESTENOSIS WAS SUBSEQUENTLY REMOVED FROM THE STUDY DATABASE BY THE CLINICAL SITE AND THIS SUPPLEMENTAL REPORT IS UPDATING THE INFORMATION PROVIDED ON THE INITIAL REPORT.
THIS MDR IS RELATED TO 3011632150-2022-00028. 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 STENTS (A 7.0 X 60MM AND A 7.0 X 80MM) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO DISTAL THIRD ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. ON THE 30-APRIL, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". THE DEVICE REMAINS IMPLANTED. ON REVIEW OF THE EVENT AT SAFETY MONITORING REVIEW (SMR) BY VERYAN, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE.
THIS MDR IS RELATED TO 3011632150-2022-00028. 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 STENTS (BM3D) (A 7.0 X 60MM - THE SUBJECT OF THIS REPORT AND A 7.0 X 80MM) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. THIS EVENT OF RESTENOSIS WAS SUBSEQUENTLY REMOVED FROM THE STUDY DATABASE BY THE CLINICAL SITE. IT WAS REVIEWED BY VERYAN ON 28-NOV-2022 AND AS A RESULT OF THE REMOVAL OF THE EVENT BY THE SITE, THIS MDR SUPPLEMENTAL IS UPDATING THE INFORMATION PROVIDED ON THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306074 | BIOMIMICS 3D VASCULAR STENT SYSTEM | BIOMIMICS 3D VASCULAR STENT SYSTEM | NIP | VERYAN MEDICAL LTD | 142122-03 | 0000052114 | 05391526850404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention| H | ASPIRIN.| ELIQUIS.| WARFARIN. |