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

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

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 devices were not returned for evaluation.A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided.Based on the information reviewed, a conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature title: everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents.The other events listed in the article are filed under other mfr report numbers.

Event Description

This report is filed for the malfunction.It was reported through a research article identifying absorb scaffolds that may be related to the following: cardiac death, thrombosis, myocardial infarction, target lesion re-vascularization, and hospitalization.Additionally, adverse events may be related to malapposition of the scaffold.Specific patient information is documented as unknown.Details are listed in the article, titled: "everolimus-eluting bioresorbable scaffoldsversus everolimus-eluting metallic stents.".

• 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: 11178688
• MDR Text Key: 227070981
• Report Number: 2024168-2021-00484
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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