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 04/24/2018

Event Type  Injury  

Manufacturer Narrative

Estimated event date.Estimated implant.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment.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 4.It was reported that this patient was featured in a journal article titled, "very late scaffold (vlsct) thrombosis after everolimus-eluting bioresorbable scaffold (brs) implantation in patients with unremarkable interim surveillance angiography".The patient underwent right coronary artery (rca) intervention with implantation of a 3.5/12 mm bioresorbable scaffold (brs).Follow-up angiography showed good results without significant restenosis.478 days after the index procedure, the patient presented with stemi (st elevation myocardial infarction).Coronary angiography showed vlsct with thrombotic occlusion of the brs in the proximal rca.After thrombus aspiration and balloon dilatation, a des (drug eluting stent) was implanted.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: 10795434
• MDR Text Key: 216642731
• Report Number: 2024168-2020-09274
• 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: 11/05/2020

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: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 71 YR