MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number 1012463-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.Date of implant - estimated.The device remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other patient events mentioned in the attached article are filed under separate medwatch report numbers.Literature.Article title: hybrid-stenting with metallic and bioresorbable drug-eluting stents 2-year clinical outcomes in kum absorb registry.

Event Description

Table 4: patient 9 it was reported through a research article that a 3x18mm absorb bvs was implanted in the distal part of the long, calcified and tapered lesion located in the left anterior descending coronary artery.A 3.5x40 drug eluting stent (des) was implanted next.428 days post implant, focal edge restenosis was noted in the bvs.Drug-eluting balloon angioplasty was performed to treat the stenosis.

Manufacturer Narrative

There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record and complaint historycould not be conducted because the part and lot number were not provided.The reported patient effect of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Na.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11126928
• MDR Text Key: 226638148
• Report Number: 2024168-2021-00157
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention