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 Intimal Dissection (1333); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of myocardial infarction, thrombosis, ischemia and dissection, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported difficulties and patient effects could not be determined.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 us.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.Literature title: bioresorbable vascular scaffolds versus drug-eluting stents for diffuse long coronary narrowings.

Event Description

It was reported through a research article identifying unk absorb that may be related to the following: delivery failure, dissection, myocardial infarction, thrombosis, ischemia, and revascularization.Additionally, the article identified unk xience that may be related to the following: delivery failure, death, myocardial infraction, thrombosis, ischemia, and revascularization.Specific patient information is documented as unknown.Details are listed in the article, titled: bioresorbable vascular scaffolds versus drug-eluting stents for diffuse long coronary narrowings.

Manufacturer Narrative

Nah6: method code 4111 removed - [(b)(4)].

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10167460
• MDR Text Key: 195561388
• Report Number: 2024168-2020-05136
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability