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 06/17/2018

Event Type  Injury  

Manufacturer Narrative

The date of event has been estimated.The date of implant has been estimated.The information received in the complaint was obtained through a proactive literature search.Specific absorb device part and lot numbers were not available and causality between the documented device usage and the patient effects could not be established.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 number were not provided.A conclusive cause for the patient effects listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.Literature.Article title: very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.The additional scaffold is being filed under a separate medwatch report number.The udi number is unknown as the part and lot #s were not provided.

Event Description

Patient 5.It was reported that this patient was featured in a journal article titled, "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold [brs] implantation in patients with unremarkable interim surveillance angiography".The patient with st elevated myocardial infarction (stemi) and subtotal occlusion of the proximal and mid right coronary artery (rca) was treated with three brs (two 3.5/28 mm and a 3.5/18 mm devices).Because of dissection at the distal edge of the distal brs, a 3.0/9 mm des was implanted.Surveillance angiography showed mild restenosis in the mid rca, with no indication for treatment.532 days after index percutaneous coronary intervention (pci), the patient suffered a recurrent myocardial infarction with very late scaffold thrombosis and subtotal thrombotic occlusion within the scaffolded segment of the mid rca.Optical coherence tomography showed focal scaffold discontinuity in the distal brs with overlying thrombus and an otherwise acceptable result in the stented segment.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 des.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10781738
• MDR Text Key: 214580702
• Report Number: 2024168-2020-09203
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 74 YR