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

Catalog Number UNK ABSORB

Device Problems Product Quality Problem (1506); Difficult or Delayed Activation (2577)

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

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Date of event and implant: estimated date.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The xience referenced is being filed under a separate medwatch report number.

Event Description

It was reported through a research article identifying absorb and xience that may be related to the following; myocardial infarction, device thrombosis, re-hospitalization and final minimal lumen diameter of the scaffold and stent.Additionally, a general statement was made regarding dissatisfaction with absorb.Specific patient information is documented as unknown.Details are listed in the attached article, titled "outcomes of optimised implantation technique with bioresorbable scaffolds: a pooled analysis of absorb-iv and compare-absorb trials".

Manufacturer Narrative

Estimated date.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history 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.The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb bioresorbable vascular scaffold system, instructions for use 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.Additionally, hospitalization appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

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: 9855709
• MDR Text Key: 187030344
• Report Number: 2024168-2020-02639
• 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,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability