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); Stenosis (2263)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction, stenosis, and thrombosis are listed in the absorb instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The xience stents and the additional adverse patient effect of death referenced are being filed under separate medwatch report numbers.Article titled: ¿three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to xience everolimus-eluting stent in routine pci in patients with diabetes mellitus¿aida substudy".

Event Description

It was reported through a research article identifying absorb bioresorbable vascular scaffold and xience everolimus-eluting stent that may be related to the following: target-vessel failure, target vessel myocardial infarction, stenosis, thrombosis, target-vessel revascularization, and cardiac deaths.No additional information was provided.Details are listed in the attached article, titled "three-year clinical outcomes of the absorb bioresorbable vascular scaffold compared to xience everolimus-eluting stent in routine pci in patients with diabetes mellitus¿aida substudy".

• 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: 10849182
• MDR Text Key: 216838948
• Report Number: 2024168-2020-09590
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability