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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Perforation (2001); Renal Failure (2041); Thrombosis (2100)

Event Date 11/01/2015

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.The devices were not returned for analysis as they remain implanted.A review of the lot history records and complaint histories could not be conducted because the lot and part numbers were not provided.The patient effects listed are consistent with the product risk profile and are therefore expected.A conclusive cause for the difficulties listed can not be determined based on the limited information available.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Article title: impact of coronary calcification on outcomes after absorb scaffold implantation: insights from the gabi-r registry.

Event Description

This is filed to report the serious injuries.It was reported through a research article identifying the absorb bioresorbable scaffolds that may be related to the following: cardiac death, target lesion revascularization, target vessel myocardial infarction, definite or probable scaffold thrombosis, major adverse cardiac events, hemorrhage, perforation, renal failure, stroke and percutaneous coronary intervention.This article summarizes clinical outcomes of 3140 patients with 3790 lesions, treated with the absorb bioresorbable vascular scaffold.Details are listed in the article titled, "impact of coronary calcification on outcomes after absorb scaffold implantation: insights from the gabi-r registry".

• 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: 10805161
• MDR Text Key: 215287398
• Report Number: 2024168-2020-09314
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR