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 Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

The patient deaths referenced will be filed under a separate medwatch report #.The xience referenced are being filed under a separate medwatch report #.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.A conclusive cause for the difficulties listed and the reported patient effects 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.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: comparison of the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with st-segment elevation myocardial infarction.

Event Description

It was reported through a research article identifying absorb that may be related to the following: patient death, myocardial infarction, thrombosis, revascularization, and rehospitalization.Additionally, it was identified that xience may be related to the following: patient death, myocardial infarction, thrombosis, revascularization, and rehospitalization.This article summarizes clinical outcomes of 264 patients that were treated with xience stents and absorb scaffolds.Specific patient information is documented as unknown.Details are listed in the article, titled "comparison of the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with st-segment elevation myocardial infarction.".

• 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: 10809951
• MDR Text Key: 215321063
• Report Number: 2024168-2020-09326
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability