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

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2013

Event Type  malfunction  

Manufacturer Narrative

Event dates estimated.The patient deaths referenced will be filed under a separate medwatch report #.The patient effects referenced will be filed under a separate medwatch report #.The additional xience referenced will be filed under a separate medwatch report #.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.A conclusive cause for the reported difficulty to deploy, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.Article title: comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.

Event Description

It was reported through a research article identifying xience that may be related to the following: patient death, myocardial infarction, thrombosis, cardiac arrest, revascularization, rehospitalization, malposition, and stents jailing or occluding vessels.Additionally, it was identified that absorb may be related to the following: patient death, myocardial infarction, thrombosis, dissection, revascularization, rehospitalization, and malposition.This article summarizes clinical outcomes of 1,845 patients that were treated with xience and absorb stents.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.

• 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: 10005822
• MDR Text Key: 189226673
• Report Number: 2024168-2020-03952
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1