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)

Event Date 02/03/2019

Event Type  Injury  

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record could not be conducted because the part and lot numbers were not provided.The reported potential adverse event of myocardial infarction and thrombosis are listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use as known adverse events associated with the use of a coronary scaffold.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.However, the additional treatment and hospitalization appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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 additional absorb device referenced is filed under a separate medwatch report number.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 was treated with a 3.0x18 mm and a 3.5x12 mm absorb bioresorbable scaffolds (brs) in the left circumflex coronary artery.Six month follow up showed a favorable result.1494 days after the index procedure, the patient presented with st elevated myocardial infarction (stemi) and angiography showed very late scaffold thrombosis with thrombotic occlusion of the brs.The area was treated with balloon dilatation and implantation of a drug eluting stent (ses).No additional information was provided.Details are in the article, titled: "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.".

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na - attachment: [cn-033974.Pdf].

• 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: 10148611
• MDR Text Key: 195022701
• Report Number: 2024168-2020-04966
• 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: 07/30/2020

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: 06/12/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABSORB BRS; ABSORB BRS
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 48 YR