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

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Event date is estimated.Implant date is estimated.The scaffold remains in the patient.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 numbers were not provided.A conclusive cause for the reported wall apposition, patient effects, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to circumstances of the procedure.The reported potential adverse events 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.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 6.It was reported that this patient was featured in a journal article titled, "very late scaffold thrombosis [vlsct] after everolimus-eluting bioresorbable scaffold [brs] implantation in patients with unremarkable interim surveillance angiography".From the article: the patient was treated with two 3.5/28 mm brs for presentation with nstemi [non st elevation myocardial infarction].Follow-up angiography at 15 months after the index pci [percutaneous coronary intervention] showed a satisfactory result.866 days after the index pci, the patient presented with stemi caused by vlsct.St-segment elevation resolved after administration of heparin in the emergency department.There was timi 3 flow by coronary angiography.Oct [optical coherence tomography] showed thrombotic material surrounding malapposed struts in the lumen of the distal rca [right coronary artery] at the site of a focal scaffold discontinuity.A des [drug eluting stent] was implanted with a good procedural result.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: 10796317
• MDR Text Key: 216644147
• Report Number: 2024168-2020-09286
• 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

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 55 YR