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 Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant: estimated.The scaffolds remain in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The patient deaths and other adverse patient events reported are filed under separate medwatch report numbers.Literature article title: hybrid-stenting with metallic and bioresorbable drug-eluting stents 2-year clinical outcomes in (b)(6) registry.

Event Description

This is filed for the patient adverse events: it was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to: death, thrombosis, stenosis, myocardial infarction, revascularization, hospitalization and treatment with medication.Specific patient information is documented as unknown.Details are listed in the attached article, titled: "hybrid-stenting with metallic and bioresorbable drug-eluting stents 2-year clinical outcomes in (b)(6) registry.".

Manufacturer Narrative

The devices remain implanted and were not returned for analysis.A review of the lot history records and complaint histories could not be conducted because the lot and part numbers were not provided.The reported patient effects of thrombosis, myocardial infarction and stenosis are listed and 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.The patient effects listed are consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 11126846
• MDR Text Key: 225558887
• Report Number: 2024168-2021-00156
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 64 YR