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); Stenosis (2263)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Estimated dates of event and implant.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 event of myocardial infarction, stenosis 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.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 7 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".Per the article: the patient presented with nstemi [non st elevation myocardial infarction] and subtotal occlusion of the proximal lad [left anterior descending coronary artery].A 3.5/18 mm brs was implanted.Six-month follow-up angiography showed an excellent result in the proximal lad.890 days after brs implantation, the patient was admitted to hospital with stemi.Coronary angiography showed vlsct with subtotal thrombotic occlusion of the scaffold in the proximal lad.Oct [optical coherence tomography] showed a focal area of mild to moderate restenosis, a tissue bridge possibly consequent on chronic malposition and focal scaffold discontinuity with thrombosis overlying malposed struts in the vessel lumen.Flow was restored after balloon dilation and des [drug eluting stent] implantation.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: 10796357
• MDR Text Key: 217331338
• Report Number: 2024168-2020-09283
• 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: 73 YR