MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Thrombosis (2100); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 12/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Mean age of patients in study is 82.Majority of patients in study were male.Average weight of patients in study was not reported; therefore, the average weight is unk.Date of event has been estimated.Date of implant has been estimated.Literature attachment: three-year results of the absorb everolimus-eluting bioresorbable vascular scaffold in infrapopliteal arteries the scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

The following information was reported through a research article titled, 'three-year results of the absorb everolimus-eluting bioresorbable vascular scaffold in infrapopliteal arteries'.It was reported that the study was to investigate the mid-term performance of the everolimus-eluting absorb bioresorbable vascular scaffold (bvs) for the treatment of symptomatic infrapopliteal atherosclerotic disease.The article identified that absorb may be related to patient thrombosis, occlusion, restenosis and pseudoaneurysms.Details are listed in the attached report.

Manufacturer Narrative

(b)(4).The udi # cannot be provided since the part and lot #s were not reported.There was no reported device malfunction and the product was not returned.The reported patient effects of occlusion, thrombosis, aneurysm and restenosis, are 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 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.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8294058
• MDR Text Key: 134638403
• Report Number: 2024168-2019-00728
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR