MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB GT1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 06/09/2015

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 device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number 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: the 1-year safety and efficacy outcomes of absorb bioresorbable vascular scaffolds for coronary artery disease treatment in diabetes mellitus patients: the absorb md benelux study.The other events listed in the article are filed under different mfr report numbers.

Event Description

It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to the following: thrombosis and myocardial infarction, requiring re-hospitalization and intervention.The patient is an (b)(6) male, with implantation of an absorb gt1 bvs in the proximal circumflex artery.Eight days post procedure, the patient presented with myocardial infarction and scaffold thrombosis was noted.The patient underwent a successful revascularization procedure.No additional information was provided.Details are listed in the article, titled the 1-year safety and efficacy outcomes of absorb bioresorbable vascular scaffolds for coronary artery disease treatment in diabetes mellitus patients: the absorb dm benelux study.

• Brand Name: ABSORB GT1 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: 10813345
• MDR Text Key: 215497106
• Report Number: 2024168-2020-09335
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 11/09/2020

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 GT1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 80 YR