MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 12/12/2014

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record for the reported lot could not be conducted because the part and lot numbers were not provided.The reported potential adverse events of myocardial infarction and thrombosis are listed in the absorb bioresorbable vascular scaffold system (bvss), instructions for use (ifu) as known adverse events associated with the use of a coronary scaffold.A conclusive cause for the reported difficulty to deploy and 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 the design, manufacture, or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Article: title: comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.The additional absorb device is being filed under a separate medwatch report number.(b)(4).

Event Description

It was reported through a research article identifying an absorb scaffold that was implanted in the mid and distal right coronary artery.The patient presented with angina.Pre-dilatation was performed with an unspecified 2.5x20mm balloon at 12 atmospheres (atms), and the 3.5x28mm absorb biodegradable scaffold was implanted at 12 atms.Pre-dilatation was performed again with an unspecified 2.5x20mm balloon at 12 atms, and another 3x18mm absorb biodegradable scaffold was implanted at 14 atms.Post-dilatation was not performed.The patient developed thrombosis and myocardial infarction (mi) 376 days later.Additionally, malapposition was noted.Type of treatment was not specified.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.".

Manufacturer Narrative

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

• 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: 9990758
• MDR Text Key: 190010571
• Report Number: 2024168-2020-03855
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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
• Treatment: ABSORB STENT.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability