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 Aneurysm (1708); Myocardial Infarction (1969); Tachycardia (2095); Thrombosis (2100); Ventricular Tachycardia (2132)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

Event date, diagnosis, implant: dates are estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.It cannot be confirmed if the device was absorb or absorb gt1.Article title: very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.

Event Description

The following was reported through a research article: it was reported that the patient presented with st- elevated myocardial infarction (stemi) and had a 3.5x28 mm absorb bioresorbable scaffold (brs) implanted in the proximal left anterior descending (lad) coronary artery.Six months follow up showed a favorable result.1440 days after the index procedure, the patient presented with a nstemi and recurrent non-sustained ventricular tachycardia.Angiography with optical coherence tomography (oct) showed very late scaffold thrombosis with thrombotic material and formation of a large aneurysm in the region of the implanted brs.The lesion was treated with a drug eluting stent.No additional information was provided.Details are in the attached article, titled: "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.".

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effect of myocardial infarction, aneurysm, thrombosis and tachycardia, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: patient code 2132 removed - attachment: [article scaffold thrombosis.Pdf].

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: 10146638
• MDR Text Key: 195266103
• Report Number: 2024168-2020-04959
• 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: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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
• 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; Disability
• Patient Age: 55 YR