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

Catalog Number 1012464-18

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

Patient Problem Stenosis (2263)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.Literature attachment: chronic total occlusion 5 years after bioresorbable vascular scaffold implantation: a serial optical coherence tomography assessment.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported in a literature article that a patient underwent a percutaneous coronary intervention with the absorb bioresorbable vascular scaffold.On 8/24/2013 the absorb scaffold was implanted in the proximal right coronary artery.At the 12 and 24 month follow-up visits, coronary angiogram and optical coherence tomography were performed.These tests showed preserved vessel patency with signs of peristrut low-intensity areas within the neointima and features of atherosclerosis progression at the distal edge of the scaffold.There were no signs of restenosis at 12 and 24 months.A scheduled follow-up angiography at 60 months revealed a total occlusion at the distal part of the scaffold.The patient did not have any symptoms.Within the proximal edge, optical coherence tomography showed a complete absorption of stent struts with neointimal proliferation and a decreased scaffold area and diameter was observed.Although the exact reason for the occlusion is unknown, the location of the occlusion points to the stent edge restenosis as the reason for occlusion.The occlusion was treated with four everolimus eluting stents.There was good stent expansion and apposition.No additional information was provided.

Manufacturer Narrative

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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B1: there was no product problem for this patient.

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: 10098722
• MDR Text Key: 193305071
• Report Number: 2024168-2020-04582
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2013
• Device Catalogue Number: 1012464-18
• Device Lot Number: 3032261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 83