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

Model Number 1235300-18

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 10/23/2021

Event Type  Injury  

Manufacturer Narrative

Implant date - estimated.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The reported patient effects of thrombosis and myocardial infarction, as listed in the absorb gt1 instructions for use (ifu), are known patient effects that may be 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.The reported 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.

Event Description

It was reported that the an absorb bioresorbable vascular scaffold (bvs) was implanted sometime in (b)(6) 2014 to treat an anterior myocardial infarct in the ramus interventricularis anterior (riva).Seven years later, on (b)(6) 2021, the patient was hospitalized with a myocardial infarct due to an angiographically proven very late thrombosis of the bvs.Of note, the bvs was fully absorbed and the area endothelialized, with only signs of the markers visible.The vessel was dilated with an unspecified 2.5 x 15 mm balloon and a non-abbott 3.5 x 23 mm stent was implanted.Patient did very well and has been discharged from the hospital.No additional information was provided.

• 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: 12756257
• MDR Text Key: 283833101
• Report Number: 2024168-2021-10014
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: 08717648213045
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1235300-18
• Device Catalogue Number: 1235300-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• 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