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 Thrombosis (2100)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history could not be conducted because the part and lot number were not provided.The reported patient effect of thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, electronic instructions for use (eifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.Article titled: "bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the italian multicenter rai registry." (b)(4).

Event Description

It was reported through a research article that absorb bioresorbable vascular scaffolds may be related to thrombosis.Specific patient information is documented as unknown.Details are listed in the article titled: "bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the (b)(6 registry.".

Manufacturer Narrative

This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Article attached titled: "bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the italian multicenter rai registry.".

• 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: 8932159
• MDR Text Key: 156289865
• Report Number: 2024168-2019-11173
• 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
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• 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): Other
• Patient Age: 59 YR