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 Problem Thrombosis (2100)

Event Date 09/01/2012

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: dates estimated.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.The patient effects listed from the literature article can not be associated to the device usage and/or malfunctions, as the causality between the documented device usage and the patient effect(s) could not be established; therefore, the determination of the reported difficulty(ies) with the patient effect(s) consideration is not feasible.A conclusive cause for the difficulties listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.Article title: potentially increased incidence of scaffold thrombosis in patients treated with absorb bvs who terminated dapt before 18 months.

Event Description

It was reported through a research article identifying absorb that may be related to the following: acute, subacute, late, and very late thrombosis, revascularization, and rehospitalization.This article summarizes clinical outcomes of 808 patients that were treated with absorb scaffolds.Specific patient information is documented as unknown.Details are listed in the attached article, titled "potentially increased incidence of scaffold thrombosis in patients treated with absorb bvs who terminated dapt before 18 months.".

• 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: 11194403
• MDR Text Key: 227546791
• Report Number: 2024168-2021-00563
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR