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 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Estimated dates.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.The scaffolds remain in the patients.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 us.Literature article."low major adverse cardiac event rates following bioresorbable vascular scaffold implantation: impact of implantation technique on treatment outcomes".Na.

Event Description

It was reported through a research article that absorb bioresorbable vascular scaffolds may be related to the following: myocardial infarction, thrombosis and in-stent restenosis which may require additional medical intervention, medication and hospitalization.Specific patient information is documented as unknown.Details are listed in the attached article titled: "low major adverse cardiac event rates following bioresorbable vascular scaffold implantation: impact of implantation technique on treatment outcomes".

Manufacturer Narrative

Implant date/ explant date: 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.Device was not returned for evaluation.Part number and lot numbers were not provided for the complaint devices; therefore, review of the lot history record, similar incidents and udi numbers cannot be provided as device part and lot number is unknown.The investigation was unable to determine a conclusive cause for the reported difficulty.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 the design, manufacture, or labeling of the device.Mfr site - contact name.

Event Description

Subsequent to the initially filed report, the following information was received: the physician reported that the patient effects of myocardial infarction and thrombosis reported in the article for absorb bioresorbable vascular scaffolds was likely related to clopidogrel resistance.No additional information was provided.Events detailed in the research article occurred during the devices ide approval period and were captured per clinical ide procedures at that time.

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 article."low major adverse cardiac event rates following bioresorbable vascular scaffold implantation: impact of implantation technique on treatment outcomes".

• 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: 8860272
• MDR Text Key: 153249514
• Report Number: 2024168-2019-10573
• 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

• 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
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 10/14/2019; 07/20/2020
• Supplement Dates FDA Received: 10/16/2019; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR