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

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Stenosis (2263)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Exemption number (b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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 reported patient effects of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use, is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.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.The xience and xience prime devices referenced are being filed under separate medwatch report numbers.

Event Description

It was reported through a research article identifying absorb, xience, and rx xience prime that may be related to the following: malapposed stents and patients experiencing restenosis whom underwent elective percutaneous coronary intervention of target lesion and target vessel revascularization.Specific patient information is documented as unknown.Details are listed in the attached article, titled ¿one-year clinical, angiographic and oct follow-up after absorb bvs implantation in long coronary artery lesions: mechanisms of coronary artery remodeling." it was reported that the study was conducted to establish the bvs absorb effectiveness and safety for long coronary lesions.60 patients with long coronary lesions (length more than 25mm) were included in the study.In accordance with the implant type all patients were randomized in 2 groups: group 1 (n=30) bvs absorb implantation, group 2 (n=30) xience v/xience prime implantation.Implant apposition was controlled by coronary angiography and optical coherence tomography (oct).Post pci follow-up included 12 month¿s observation period.Elective coronary angiography and oct control were performed after 12 months at all patients.In oct minimal, maximal, mean diameter and area of lumen in stenting zone, amount of malapposed, protruding and uncovered struts, as well as neointima thickness and area was calculated.For group 1, three patients underwent elective percutaneous coronary intervention of target lesion due to bvs restenosis and one underwent target vessel revascularization.In group 2, there was two cases of target lesion revascularization due to restenosis.In 12 month 2d oct analysis revealed significant reduction of minimal lumen diameter, maximal lumen diameter and mean lumen area in both groups.Both types of implants allow to obtain equivalent 12 months clinical results.Despite of achievement of greater lumen area after xience v/xience prime drug eluting stent implantation, bvs is associated with more smooth and thin neointima proliferation and the presence of less number of malapposed and especially uncovered struts.No additional information was provided.

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: 8962759
• MDR Text Key: 159518377
• Report Number: 2024168-2019-11447
• 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: 09/04/2019
• 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): Required Intervention