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

Catalog Number UNK ABSORB

Device Problem Off-Label Use (1494)

Patient Problems Death (1802); Sepsis (2067)

Event Date 06/01/2018

Event Type  Death  

Manufacturer Narrative

Date of death estimated as (b)(6) 2018.Date of event estimated as (b)(6) 2018.Date of implant estimated as (b)(6) 2017.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional adverse events referenced are being filed under a separate medwatch report #.Article title: early and midterm experience with the absorb everolimus-eluting bioresorbable vascular scaffold in asian patients with chronic limb-threatening ischemia: one-year clinical and imaging outcomes from the disappear registry.

Event Description

It was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to death and serious injury.Specific patient information is documented as unknown.Details are listed in the attached article, titled early and midterm experience with the absorb everolimus-eluting bioresorbable vascular scaffold in asian patients with chronic limb-threatening ischemia: one-year clinical and imaging outcomes from the disappear registry.

Manufacturer Narrative

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 of the reported lot could 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 is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.In this article, the bvs was used in the lower extremities.It should be noted that the device ifu states: the absorb bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.It is unknown if the ifu deviation contributed to the reported event.Based on the case information and related record review, a conclusive cause for the reported 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 design, manufacture or labeling of the device.The udi # is unknown as the part and lot numbers were not provided.Patient code: sepsis added.(b)(4).

• 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: 10178962
• MDR Text Key: 195929320
• Report Number: 2024168-2020-05199
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• 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: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR