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 Death (1802); Hematoma (1884); Myocardial Infarction (1969); Perforation (2001); Thrombosis (2100); Cardiac Tamponade (2226)

Event Date 09/19/2016

Event Type  Death  

Manufacturer Narrative

Outcomes to adverse event, date of event: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional adverse patient effects referenced are being filed under a separate medwatch report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

It was reported in a research article that absorb bioresorbable scaffolds (brs) may be related to death, target vessel failure, scaffold thrombosis, myocardial infarction, revascularization, hospitalization, perforation with intervention, tamponade with pericardiocentesis, and femoral hematoma.Additional information can be found in the attached article "procedural and long-term outcomes of bioresorbable scaffolds versus drug-eluting stents in chronic total occlusions".

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Product performance engineering reviewed the incident information; however, 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 not be conducted because the part and lot number were not provided.The reported patient effect of death, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 11368792
• MDR Text Key: 233239783
• Report Number: 2024168-2021-01394
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death