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

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.Exemption number (b)(4).The scaffolds remain in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional patient effect of death referenced is being filed under a separate medwatch report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

Details are listed in the attached article, titled ¿poly (l-lactic acid) bioresorbable scaffolds versus metallic drugeluting stents for the treatment of coronary artery disease: a meta-analysis of 11 randomized trials." it was reported through a research article identifying absorb bioresorbable vascular scaffolds that may be related to the following: patients experiencing cardiovascular mortality, myocardial infarction, restenosis, target lesion failure, ischemic complications, thrombosis related to malapposed scaffolds and target lesion revascularization.No additional information was provided.

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.The reported patient effects of myocardial infarction, ischemia, thrombosis, and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.Based on the information reviewed, a conclusive cause for the reported difficulties and patient effects could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Literature attachment: ¿poly (l-lactic acid) bioresorbable scaffolds versus metallic drugeluting stents for the treatment of coronary artery disease: a meta-analysis of 11 randomized trials".Na.

• 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: 9387074
• MDR Text Key: 168457159
• Report Number: 2024168-2019-13996
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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; Required Intervention; Disability
• Patient Age: 62 YR