MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

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

Patient Problem Intimal Dissection (1333)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Udi # - in the absence of reported part number, udi could not be provided.Exemption number (b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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.Based on the case information a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of dissection, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Attached, article title: "acute angiographic and intermediate-term clinical results of patients with non-left main coronary bifurcation lesions treated with bvs by jailed semi-inflated balloon technique and provisional side-branch stenting strategy." the absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported through a research article that the abbott bioresorbable vascular scaffold may be related to some dissections that occurred during the coronary procedure.Details are listed in the attached article, titled acute angiographic and intermediate-term clinical results of patients with non-left main coronary bifurcation lesions treated with bvs by jailed semi-inflated balloon technique and provisional side-branch stenting strategy.

Manufacturer Narrative

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

• Brand Name: ABSORB
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9377412
• MDR Text Key: 168058736
• Report Number: 2024168-2019-13926
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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