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

Catalog Number UNK ABSORB

Device Problem Failure to Advance (2524)

Patient Problems Aneurysm (1708); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 12/15/2012

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: dates estimated.The patient deaths referenced will be filed under a separate medwatch report #.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.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 number were not provided.The reported patient effects of myocardial infarction, thrombosis and anuerysm, 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.Based on the information reviewed, a conclusive cause for the 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.The udi is unknown as the part and lot numbers were not provided.Article title: bioresorbable scaffold implantation in stemi patients: 5 years imaging subanalysis of prague-19 study.

Event Description

It was reported through a research article identifying absorb that may be related to the following: patient death, myocardial infarction, thrombosis, aneurysm, revascularization, and rehospitalization.Also some absorb delivery systems failed to cross the lesion.This article summarizes clinical outcomes of 79 patients that were treated with absorb scaffolds.Specific patient information is documented as unknown.Details are listed in the attached article, titled "bioresorbable scaffold implantation in stemi patients: 5 years imaging subanalysis of prague-19 study.".

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11195225
• MDR Text Key: 227569957
• Report Number: 2024168-2021-00566
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: EZ
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR