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 Problem Death (1802)

Event Date 05/01/2014

Event Type  Death  

Manufacturer Narrative

Date of death - estimated.Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.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 effect of death, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported death, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment.Article title ¿biosolve-iv-registry: safety and performance of the magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients".The other serious adverse effects mentioned are filed under another medwatch report number.

Event Description

This is filed for the patient deaths: it was reported through a research article identifying the absorb bioresorbable vascular scaffold (bvs) that may be related to the following: death, thrombosis, myocardial infarction, revascularization and re-hospitalization.Specific patient information was not provided.Details are listed in the attached article, titled biosolve-iv-registry: safety and performance of the magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.Please see article for additional information.

• 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: 10623864
• MDR Text Key: 209743567
• Report Number: 2024168-2020-08244
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death