ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
Report
- Report Number
- 2024168-2020-05209
- Event Type
- Injury
- Date Received
- June 22, 2020
- Date of Event
- July 6, 2018
- Report Date
- December 22, 2020
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- PNY
- UDI-DI
- 08717648213045
- PMA / PMN Number
- P150023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE REMAINED IMPLANTED AND IS NOT RETURNING FOR ANALYSIS. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED REPORTING ADDITIONAL, RELEVANT INFORMATION. LITERATURE ATTACHED: ¿OVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION¿B3: ESTIMATED DATE. THE ARTICLE REPORTS A NEW DATE OF OCCURRENCE AS ONE YEAR FOLLOWING THE INDEX PROCEDURE WHICH WAS PERFORMED ON (B)(6)2017. THE DATE OF OCCURRENCE HAS BEEN ESTIMATED AS (B)(6)2018.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.B3: ACTUAL DATE OF EVENT.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND RESTENOSIS AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.B6:(B)(6)2019 : CORONARY ANGIOGRAM REMOVED AND REPLACED WITH THE CORRECT YEAR, (B)(6)2017 .
SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: THIS PATIENT EVENT WAS ALSO CAPTURED IN A PUBLISHED ARTICLE TITLED " OVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION¿ IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE 3.0X18MM ABSORB GT1 SCAFFOLD WAS IMPLANTED WITHOUT A DEVICE ISSUE. PER OPTICAL COHERENCE TOMOGRAPHY, THE SCAFFOLD WAS COMPLETELY EMBEDDED IN THE VASCULAR ENDOTHELIUM. 12 MONTHS LATER AND PER IMAGING, THERE WAS NO RESTENOSIS, HOWEVER, THERE WAS DISCONTINUITY OF THE BVS AND SOME STRUTS APART FROM THE VESSEL. TORN STRUTS OVERHANGING INTO THE VASCULAR LUMEN, REMAINING STATIONARY ON THE ENDOTHELIUM AND RESISTANT TO CORONARY BLOOD FLOW WERE ALSO OBSERVED. DURING A FOLLOW-UP CATHERIIZATION, THE VESSEL WALL OF THE PROXIMAL SITE OF THE OVERHANGING BVS SHOWED POSITIVE REMODELING AND THERE WERE NO ATTACHED STRUTS. THE PHYSICIANS SPECULATE THAT PROMPT POSITIVE REMODELING CAUSED EARLY DISLODGEMENT AND SCHEDULED DEGENERATION OF THE DISLODGED STRUTS CAUSING THEM TO ROLL UP AND FALL ONTO THE DISTAL SIDE. DUAL ANTIPLATELET THERAPY WAS PROVIDED WITHOUT ANY ADVERSE EVENTS FOR 2 YEARS AFTER PCI.. DETAILS ARE FOUND IN THE ATTACHED ARTICLE: ¿OVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION¿
SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED:(B)(6)2018 DISCONTINUITY OF THE BVS AND SOME STRUTS APART FROM THE VESSEL WERE OBSERVED.
THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.
PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2017, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (RCA) LESION. FOLLOWING PRE-DILATATION, A 3.0X18MM ABSORB GT1 SCAFFOLD (1235300-18, 6100461) WAS SUCCESSFULLY IMPLANTED IN THE DISTAL RCA. ON (B)(6) 2017, ANOTHER PCI WAS PERFORMED. FOLLOWING PRE-DILATATION, A 3.0X23MM ABSORB SCAFFOLD (1235300-23, 6101161) WAS SUCCESSFULLY IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. THERE WERE NO ADVERSE EVENTS AND THERE WAS NO DEVICE MALFUNCTION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED. A CORONARY ANGIOGRAM WAS PERFORMED AND SILENT MYOCARDIAL ISCHEMIA DIAGNOSED. THE DISTAL RCA, 3.0X18MM ABSORB SCAFFOLD, WAS OBSERVED WITH RESTENOSIS AND A FLARED STRUT. AS TREATMENT, AN ATHERECTOMY WAS PERFORMED. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO RESTENOSIS AND NO DEVICE ISSUE REGARDING THE 1ST DIAGONAL, 3.0X23MM ABSORB SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643775 | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM | BIORESORBABLE SCAFFOLD | PNY | ABBOTT VASCULAR | 1235300-18 | 6100461 | 08717648213045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R | 1 IMPLANTED ABSORB SCAFFOLD. |