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

Catalog Number UNK ABSORB

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

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

The date of event and implant is estimated to be (b)(6) 2015.There was no reported device malfunction and the product was not returned.A review of the lot history record for the reported lot could not be conducted because the part and lot numbers were not provided.The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use (ifu) as known adverse events associated with the use of a coronary scaffold.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The patient deaths referenced are being filed on a separate medwatch report #.Literature.¿article title- predictors of long-term adverse events after absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries".

Event Description

It was reported through a research article identifying the absorb scaffold that may be related to death and serious injury.Specific patient information is documented as unknown.Details are listed in the article, titled, predictors of long-term adverse events after absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries.

Manufacturer Narrative

C4: therapy date estimated.This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na - attachment: [article cn-032113.Pdf].

• 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: 10087921
• MDR Text Key: 192156914
• Report Number: 2024168-2020-04492
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR