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 Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); No Code Available (3191)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant: estimated.The devices are not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported through a research article identifying the absorb bioresorbable vascular scaffold that was related to the following outcomes: myocardial infarction, thrombosis, ischemia and delayed endothelialization.Specific patient information is documented as unknown.Details are listed in the article, titled imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: the meres-1 extend trial.

Manufacturer Narrative

The devices were not returned for evaluation.A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction, thrombosis and ischemia, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, electronic instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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.Article attached: imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: the meres-1 extend trial.

• 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: 11090020
• MDR Text Key: 224322497
• Report Number: 2024168-2020-10984
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability