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 Intimal Dissection (1333); Hematoma (1884); Thrombosis (2100); Prolapse (2475)

Event Date 11/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event has been estimated.Implant date has been estimated.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.The investigation was unable to determine a conclusive cause for the reported complaints.A conclusive cause for the reported patient effects of intimal dissection, hematoma, thrombosis, prolapse and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The additional malfunctions referenced are being filed under a separate medwatch report #.

Event Description

It was reported through a research article identifying absorb bioresorbable vascular scaffold (bvs) that may be related to the following: under-expansion, malposition, edge dissection, thrombus and or plaque protrusion, scaffold fracture, and intramural hematoma.Specific patient information is documented as unknown.Details are listed in the attached article, titled absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.

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: 9700369
• MDR Text Key: 180334689
• Report Number: 2024168-2020-01405
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR