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 Problems Intimal Dissection (1333); Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.Implant date: estimated.The devices were not returned for analysis.A review of the lot history records and complaint histories could not be conducted because the lot and part numbers were not provided.The patient effects listed are consistent with the product risk profile and are therefore expected.A conclusive cause for the difficulties listed cannot be determined based on the limited information available.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.Article titled: "angiographically based direct implantation of the bioresorbable vascular scaffold in non-st segment elevation acute coronary syndrome: feasibility and outcome.".

Event Description

It was reported through a research article identifying absorb scaffold that may be related to the following: myocardial infarction, dissection, in-stent thrombosis, chest pain, re-intervention and hospitalization.Details are listed in the article, titled ¿angiographically based direct implantation of the bioresorbable vascular scaffold in non-st segment elevation acute coronary syndrome: feasibility and outcome.¿.

• 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: 10814338
• MDR Text Key: 215488014
• Report Number: 2024168-2020-09359
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR