MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

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

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 03/11/2014

Event Type  Death  

Manufacturer Narrative

Dates of death, event, and implant: dates estimated.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 death, 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 udi is unknown as the part and lot numbers were not provided.

Event Description

It was reported through a research article identifying an absorb scaffold that was implanted in the proximal right coronary artery.The patient presented with a non-st elevated myocardial infarction (mi).Pre-dilatation was performed with an unspecified 3x15mm balloon at 12 atmospheres (atms), and the 3.5x12mm absorb biodegradable scaffold was implanted at 14 atms.Post-dilatation was performed with an unspecified 3.5x8mm balloon at 22 atms.The patient developed thrombosis, mi, and subsequently died 100 days later.Type of treatment, if any, was not specified.Specific patient information is documented as unknown.Details are listed in the article, titled "comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.".

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.(b)(4).

• Brand Name: ABSORB
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10006287
• MDR Text Key: 189215831
• Report Number: 2024168-2020-03964
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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): Death