MAUDE Adverse Event Report: ABBOTT ABBOTT ABSORB BIOABSORBABLE VASCULAR SCAFFOLD; CORONARY DRUG ELUTING STENT

Lot Number 6082961

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Date 03/06/2017

Event Type  Injury  

Event Description

Pt had three abbott absorb bioabsorbable scaffolds placed on (b)(6) 2017 (x2 to lad and x1 to circumflex artery).She was found to have a stent thrombosis of the bioabsorbable scaffold in the mid left circumflex coronary artery and required a repeat percutaneous intervention for add'l stent placement.

• Brand Name: ABBOTT ABSORB BIOABSORBABLE VASCULAR SCAFFOLD
• Type of Device: CORONARY DRUG ELUTING STENT
• Manufacturer (Section D): ABBOTT; abbott park IL
• MDR Report Key: 7534265
• MDR Text Key: 109058583
• Report Number: MW5077391
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2018

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 Lot Number: 6082961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 83