MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB GT1

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Implant date estimated.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional device referenced is being filed under a separate medwatch report number.The patient deaths referenced are being filed under a separate medwatch report number.Literature attachment.Article title ¿everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective absorb dm benelux study, twente and dutch peers¿.

Event Description

It was reported through a research article identifying that absorb and absorb gt1 may be related to the following: death, myocardial infarction, thrombosis, target lesion failure, rehospitalization and revascularization.This article summarizes clinical outcomes of 150 patients that were treated with absorb and absorb gt1 scaffolds.Specific patient information is documented as unknown.Details are listed in the attached article, titled "everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective absorb dm benelux study, twente and dutch peers.".

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 history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of myocardial infarction and thrombosis, as listed in the absorb gt1 instructions for use (ifu), are known patient effects that may be associated with the use of a coronary scaffold in native coronary arteries.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 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.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11414989
• MDR Text Key: 234744463
• Report Number: 2024168-2021-01719
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB GT1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR