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

Catalog Number UNK ABSORB

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

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

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: estimated date of event.Date of implant: estimated date of implant.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 xience stent referenced is being filed under a separate medwatch report number.Literature: the influence of implantation techniques on lesion oriented-outcomes in absorb bvs and xience ees lesions treated in routine clinical practice at complete three year follow-up: aida trial qca substudy.

Event Description

It was reported through a research presentation identifying absorb bvs and xience stents that may be related to the following: myocardial infarction, thrombosis, revascularization and rehospitalization.Deployment difficulty was also noted for both absorb bvs and xience stents, which may have caused or contributed to the adverse effects.This article summarizes clinical outcomes of 1,845 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the article, titled "the influence of implantation techniques on lesion oriented-outcomes in absorb bvs and xience ees lesions treated in routine clinical practice at complete three year follow-up: aida trial qca substudy.".

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.It should be noted that the ifu states: size the reference target lesion diameter appropriately to avoid over expanding the scaffold to ensure adequate scaffold apposition.This will reduce the risk of causing scaffold damage.It is unknown if the ifu deviation contributed to the reported difficulty.Based on the information reviewed, a conclusive cause for the reported difficulties and patient effects could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10788646
• MDR Text Key: 214738647
• Report Number: 2024168-2020-09246
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability