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

Catalog Number 1234350-23

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

Patient Problems Aneurysm (1708); Stenosis (2263)

Event Date 05/18/2023

Event Type  Injury  

Event Description

The article describes late acquired coronary aneurysm and restenosis in a patient after implantation of a 3.5x23mm absorb bioresorbable vascular scaffold (bvs).The bvs scaffold was implanted on (b)(6) 2017, in the mid left circumflex artery.Six years after scaffold implantation, on (b)(6) 2023, computed tomography coronary angiography (ctca) showed in-segment restenosis in between two newly formed coronary aneurysms at the site of the implanted bvs.On (b)(6) 2023, a dragonfly optis imaging catheter was used to guide percutaneous intervention with a new metallic drug-eluting stent (des) for treatment.Follow-up was performed on (b)(6) 2023; ctca confirmed the successful des implantation with patency of the obtuse marginal branch emerging from the stented segment and a near-complete disappearance of the aneurysmatic lesions.The article concluded computed tomography coronary angiography is an advantage for follow-up assessments, allowing clinicians to track changes over time and to make treatment adjustments as needed.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of aneurysm and stenosis are 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.A conclusive cause for the reported patient effects, 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; therefore, no product-related corrective action will be implemented in this case.There is no adverse event or device issue reported against the dragonfly optis imaging catheter mentioned in b5.Literature attachment: article title " late acquired coronary aneurysm and restenosis after bioresorbable vascular scaffold implantation: a case report".

• 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: 18937858
• MDR Text Key: 338067180
• Report Number: 2024168-2024-03529
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2017
• Device Catalogue Number: 1234350-23
• Device Lot Number: 6060961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male