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 Problem Stenosis (2263)

Event Date 05/29/2016

Event Type  Injury  

Manufacturer Narrative

Event and implant dates are estimated.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 stenosis is listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use as a known adverse event 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 being filed under a separate medwatch report number.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 non st elevated myocardial infarction (nstemi) and a 3.0x28 mm absorb bioresorbable scaffold (brs) was implanted in the left circumflex (lcx) coronary artery.A stenosis of the medial left anterior descending (lad) coronary artery was also treated with a 3.0x28 mm absorb brs.Six month follow up showed a favorable result in both areas.514 days after the index procedure, the patient presented with stemi and thrombotic occlusion of the brs in the lcx.Flow was restored after balloon dilatation and implantation of a drug eluting stent (des).The lad lesion also showed diffuse in stent restenosis which was treated with a des.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

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: 10145096
• MDR Text Key: 195369595
• Report Number: 2024168-2020-04929
• 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: 07/29/2020

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: 07/20/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.0X28 MM ABSORB
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR