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/Thrombus (4440)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

B3: date of event estimated.D6: date of implant estimated.D4: the udi is unknown as the part/lot number was not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of thrombosis and myocardial infarction are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use as known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effects of thrombosis and myocardial infarction, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effect of death reported in the article are captured under separate medwatch report.Literature attachment e-186987 article, titled: "impact of post-implantation time on bioresorbable vascular scaffold outcomes for type c versus non-type c coronary lesions: a longer-term study.".

Event Description

It was reported that this article titled, "impact of post-implantation time on bioresorbable vascular scaffold outcomes for type c versus non-type c coronary lesions: a longer-term study" captured outcomes of 457 consecutive patients who had a bioresorbable vascular scaffold implanted between march 2014 and april 2018.The article states, "with a median follow-up of 56.4 (48.6 to 62.6) months, the incidence of cardiac death, target vessel mi [myocardial infarction], tlr [target lesion revascularization], tlf [target lesion failure], and definite/probable scaffold thrombosis for the patients was 0.2%, 1.3%, 7%, 7.4%, and 0.7%, respectively." adverse patient effects included cardiac death, target vessel mi, and clinically driven percutaneous or surgical tlr.Please see the attached article for additional information.

• 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: 18066919
• MDR Text Key: 327306747
• Report Number: 2024168-2023-12235
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male