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

Catalog Number UNK ABSORB

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

Patient Problem Thrombosis (2100)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is not returning.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.Attachment - article, clinical use of intracoronary imaging.Part 1: guidance and optimization of coronary interventions.An expert consensus document of the european association of percutaneous cardiovascular interventions (b)(4).

Event Description

It was reported that through an article titled, "clinical use of intracoronary imaging.Part 1: guidance and optimization of coronary interventions.An expert consensus document of the european association of percutaneous cardiovascular interventions" involving the largest cohort study on very late absorb bvs scaffold thrombosis studied by oct - the independent oct registry on very late bioresorbable scaffold thrombosis (invest) included 36 patients with available oct at the time point of the thrombotic event; 31% of patients had serial oct imaging.The leading associated finding was new bioresorption-specific phenomenon called strut discontinuity (43%).Although most mechanisms of scaffold thrombosis are identical with metallic drug-eluting stents, stent discontinuity represents a specific finding in scaffold thrombosis.The newly described mechanism of absorb bvs failure has not been observed with metallic des and potentially explains the increased risk of very late scaffold thrombosis.

Manufacturer Narrative

(b)(4).The udi is unknown because the part number was not provided.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.The reported patient effects of thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event 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 number was not provided.Based on the information reviewed, a conclusive cause for the reported patient effects could not be determined, however the reported scaffold discontinuities appear to be related to the circumstances of the procedure.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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7622788
• MDR Text Key: 111833039
• Report Number: 2024168-2018-04724
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention