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); Stenosis (2263)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

The majority of patients were over or equal to (b)(6) of age.The majority of patients were male.The device was implanted and will not return for analysis.Investigation is not complete.A follow-up report will be submitted with all relevant information.Literature attachment: "2-year outcomes with the absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy." the additional patient effects and the xience stent referenced, are being filed under a separate medwatch report number.

Event Description

It was reported through a research article identifying the absorb scaffold and xience stent may be related to target vessel myocardial infarction (mi), mi, device thrombosis, cardiac death, death, ischemia-driven target lesion revascularization, and restenosis specific patient information is documented as unknown.Details provided in the attached article titled: "2-year outcomes with the absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy.¿.

Manufacturer Narrative

A2: the majority of patients were over or equal to 63 years of age a3: the majority of patients were male b3, d6: estimated d4: unique device identifier (udi): in the absence of reported part number, udi cannot be calculated.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.It should be noted that the reported patient effect of thrombosis, myocardial infarction, ischemia and restenosis, as listed in the bioresorbable vascular scaffold system, absorb, instructions for use, as known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to 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: 10094094
• MDR Text Key: 193065401
• Report Number: 2024168-2020-04537
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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; Disability
• Patient Age: 63 YR