MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number 1012464-28

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

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.Date of implant: estimated.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The patient effects listed are consistent with the product risk profile and are therefore expected.A conclusive cause for the difficulties listed 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 of the device.The other events mentioned in the article are filed under other mfr report numbers.Article title "one-year results following a pre-specified absorb implantation strategy in st-elevation myocardial infarction (bvs stemi strategy it study)".

Event Description

It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that after pre-dilatation of the lesion in the proximal right coronary artery, a 3.5x28mm absorb scaffold was implanted and post dilated.Two months post-implant, the patient experienced a myocardial infarction and scaffold thrombosis.Treatment included percutaneous coronary intervention with a drug-eluting bioresorbable scaffold implanted.Details are listed in the attached article, titled "one-year results following a pre-specified absorb implantation strategy in st-elevation myocardial infarction (bvs stemi strategy-it study)".Please see article for additional information.Specifically, this event captures case 4 from table 3 in the article.

• 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: 10805665
• MDR Text Key: 215325219
• Report Number: 2024168-2020-09317
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012464-28
• 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
• Patient Age: 55 YR