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 Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

Date are estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.It cannot be confirmed if the device was absorb or absorb gt1.The 2 additional absorb devices referenced are being filed under separate medwatch report numbers.Attachment: article titled: very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.

Event Description

The following was reported through a research article: it was reported that the patient presented with stemi and subtotal occlusion of the proximal and mid right coronary artery (rca).The patient was treated with three absorb bioresorbable scaffolds (brs).Two 3.5x28 mm and one 3.5x15 mm were implanted.Post implant, a distal edge dissection was noted on the distal brs, and a drug eluting stent was implanted to cover the dissection.Angiography post implantation showed mild restenosis in the mid rca, with no indication for treatment.532 days after the index procedure, the patient suffered recurrent myocardial infarction with very late scaffold thrombosis (vlsct) and subtotal thrombotic occlusion within the scaffolded segment of the mid rca.Optical coherence tomography (oct) showed scaffold discontinuity in the distal brs with overlying thrombus.In addition, there was restenosis with an oct-derived percent lumen area stenosis of 54%.The lesion was treated with balloon dilation followed by implantation of a drug eluting stent.No additional information was provided.Details are in the attached article, titled: "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.".

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of thrombosis, stenosis and myocardial infarction, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events 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 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.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10145936
• MDR Text Key: 195368222
• Report Number: 2024168-2020-04942
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 06/16/2020; 07/20/2020
• Supplement Dates FDA Received: 07/06/2020; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 ABSORB BRS
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 74 YR