MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The date of event has been estimated.The date of implant has been estimated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.A conclusive cause for the reported difficulty to deploy and patient effects, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to circumstances of the procedure.The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use (ifu) as known adverse events associated with the use of a coronary scaffold.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature.Article title: very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.The udi number is unknown as the part and lot #s were not provided.

Event Description

Patient 1.It was reported that this patient was featured in a journal article titled, "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography".A 3.0x18 mm absorb scaffold was implanted in the right coronary artery.Per the article, 393 days after the index procedure, the patient presented with st-elevation myocardial infarction (stemi) and vlsct (very late scaffold thrombosis).Intraprocedural oct (optical coherence tomography) examination showed scaffold discontinuity with malapposed struts in the vessel lumen and overlying thrombus.Flow was restored with thrombus aspiration and balloon dilatation with good acute angiographic result.46 days later the patient suffered recurrent vlsct, this time under ongoing dual antiplatelet therapy with prasugrel.Oct examination of the culprit lesion was repeated and showed more marked scaffold discontinuity with overlying thrombus.The patient was treated with a metallic drug-eluting stent (des) with good result.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.A conclusive cause for the reported wall apposition and patient effects, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Corrected verbiage from previously filed mdr.Replaced "reported difficulty to deploy" with "reported wall apposition".

• Brand Name: ABSORB
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10788499
• MDR Text Key: 214790561
• Report Number: 2024168-2020-09243
• 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
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 53 YR