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 Problem Thrombosis (2100)

Event Date 12/03/2016

Event Type  Injury  

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record could not be conducted because the part and lot numbers were not provided.The reported potential adverse event of thrombosis is listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use as a known adverse event associated with the use of a coronary scaffold.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.However, the additional treatment and hospitalization appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.Article titled, very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.

Event Description

The following was reported through a research article: it was reported that the patient had two 2.5 mm absorb bioresorbable scaffolds (brs) implanted in the right coronary artery for a length of 36 mm.Angiographic follow up confirmed favorable results.702 days after the index procedure, the patient presented with very late scaffold thrombosis and occlusion in the distal scaffold.The area was treated with balloon dilatation and stent implantation.Details are in the attached article, titled: "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography".

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: 10143699
• MDR Text Key: 194813797
• Report Number: 2024168-2020-04919
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABSORB BRS; ABSORB BRS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR