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 Myocardial Infarction (1969)

Event Date 12/01/2012

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.Exemption number (b)(4).The device will not be returned for evaluation as the scaffolds remain in the patients.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Literature."three and half year experience of bioresorbable vascular scaffold implantation in routine clinical practice in a single centre in india." (b)(4).

Event Description

It was reported through a research article that absorb bioresorbable vascular scaffolds may be related to the following: myocardial infarction and surgical / percutaneous coronary intervention (pci) target lesion revascularization.Specific patient information is documented as unknown.Details are listed in the article titled: "three and half year experience of bioresorbable vascular scaffold implantation in routine clinical practice in a single centre in india.".

Manufacturer Narrative

Estimated dates.Exemption number e2019001-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.The devices were not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The reported patient effects of myocardial infarction and surgery are listed in the instructions for use, bvss, absorb, as potential adverse effects that may be associated with percutaneous coronary intervention, treatment procedures and the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.- contact name.

Manufacturer Narrative

D4: the unique device identifier (udi) is unknown because the part and lot numbers were not provided.This report is resubmitted to ensure the enclosed attachment can be easily opened by the fda.Attachment: literature attachment."three and half year experience of bioresorbable vascular scaffold implantation in routine clinical practice in a single centre in india.".

• 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: 8864964
• MDR Text Key: 153399917
• Report Number: 2024168-2019-10594
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• 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): Hospitalization; Required Intervention; Disability