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); Sepsis (2067)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

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 absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.Article attachment: use of bioresorbable vascular scaffold technology in treating coronary bifurcation lesions: a report about long-term clinical results and review of available literaturena.

Event Description

It was reported through a research article identifying absorb scaffolds that may be related to the following; all cause deaths (sepsis) and cardiac deaths.Specific patient information is documented as unknown.Details are listed in the attached article, titled "use of bioresorbable vascular scaffold technology in treating coronary bifurcation lesions: a report about long-term clinical results and review of available literature".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot and part numbers were not provided.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.Article attachment: use of bioresorbable vascular scaffold technology in treating coronary bifurcation lesions: a report about long-term clinical results and review of available literature.

• 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: 10824363
• MDR Text Key: 215865949
• Report Number: 2024168-2020-09409
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR