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 Problem Death (1802)

Event Date 12/11/2017

Event Type  Death  

Manufacturer Narrative

Event/death was estimated as (b)(6) 2017 implant date was estimated as (b)(6) 2012 the device remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional adverse patient effects referenced in b5 are being filed under a separate medwatch report#.Literature attachment.Article title: the state of the absorb bioresorbable scaffold consensus from an expert panel.Na.

Event Description

It was reported through a research article identifying absorb that may be related to the following: death, target lesion failure, ischemia, myocardial infarction, thrombosis, and treatments with target lesion revascularization.Specific patient information is documented as unknown.Details are listed in the attached article, titled: the state of the absorb bioresorbable scaffold consensus from an expert panel.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown because the part and lot #s were not provided.Article attachment: the state of the absorb bioresorbable scaffold consensus from an expert panel.

• 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: 11117921
• MDR Text Key: 225109921
• Report Number: 2024168-2021-00082
• 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: 01/05/2021
• 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: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death