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 Death (1802)

Event Date 04/09/2019

Event Type  Death  

Manufacturer Narrative

Outcomes to adverse event, date of event, implant date: dates estimated.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 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.A conclusive cause for the reported death can not be determined based on the limited information available.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Article attachment: clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease¿aida trial substudy.The additional adverse patient effects referenced are being filed under a separate medwatch report#.The xience device referenced is being filed under a separate medwatch report#.The udi is unknown because the part and lot #s were not provided.

Event Description

It was reported through a research article identifying absorb bioresorbable vascular scaffold (bvs) and xience evorolimus eluting stent (ees) that may be related to the following: death, myocardial infarction, revascularization, thrombosis, stenosis.Specific patient information is documented as unknown.Details are listed in the attached article, titled: clinical outcomes at 2 years of the absorb bioresorbable vascular scaffold versus the xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease¿aida trial 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: 10814006
• MDR Text Key: 215456000
• Report Number: 2024168-2020-09346
• 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: 11/09/2020

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?: No
• 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: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR