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 Thrombosis (2100); Stenosis (2263)

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.Date of event has been estimated.Date of implant has been estimated.Literature: the demise of the absorb bvs: lessons learned from the discontinuation of a disappearing stent.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device malfunctions referenced in the article are being filed under a separate medwatch report.

Event Description

It was identified through review of the article that the absorb bioresorbable vascular scaffold (bvs) may be related to patient thrombosis, restenosis, re-hospitalization and re-vascularization.Details are listed in the article, titled, "the demise of the absorb bvs: lessons learned from the discontinuation of a disappearing stent".

Manufacturer Narrative

(b)(4).In the absence of reported part number, udi cannot be calculated.There was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of thrombosis and restenosis, are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use as known adverse events associated with the use of a coronary scaffold in native coronary arteries.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: 8297567
• MDR Text Key: 134759956
• Report Number: 2024168-2019-00759
• 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: 02/01/2019
• 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: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention