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 Occlusion (1984); Thrombosis (2100); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.There were no reported device malfunctions and the products were not returned as the scaffolds remain in the anatomies.A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided.The reported patient effects of restenosis, thrombosis, occlusion and pseudoaneurysm, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, 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.Article title: "long-term results of a prospective, single-arm evaluation of everolimus-eluting bioresorbable vascular scaffolds in infrapopliteal arteries".The patient effect of death is filed under a separate medwatch report number.

Event Description

It was reported through a research article identifying the absorb bioresorbable scaffolds that may be related to the following: death, restenosis, scaffold thrombosis, occlusion, pseudoaneurysm, target lesion revascularization and rehospitalization.This article summarizes clinical outcomes of 48 patients, 55 limbs, treated with 71 absorb scaffolds.Details are listed in the article titled, "long-term results of a prospective, single-arm evaluation of everolimus-eluting bioresorbable vascular scaffolds in infrapopliteal arteries." please see article for additional information.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10773355
• MDR Text Key: 214774766
• Report Number: 2024168-2020-09119
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR