MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR ABSOBABLE STENT; ABSORBABLE STENT

Model Number 123535018

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Date 11/27/2016

Event Type  Injury  

Event Description

Patient undergoing multi-vessel pci by absorbable stent placed in the lad.While performing pci on circ, thrombus formed at the site of the lad stent.

• Brand Name: ABBOTT VASCULAR ABSOBABLE STENT
• Type of Device: ABSORBABLE STENT
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA
• MDR Report Key: 6148683
• MDR Text Key: 61621751
• Report Number: 6148683
• Device Sequence Number: 1
• Product Code: PNY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 123535018
• Device Catalogue Number: 123535018
• Device Lot Number: 6071961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2016
• Distributor Facility Aware Date: 11/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2016
• 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
• Treatment: ASA DAILY; EFFIENT; HEPARIN AGGRASTAT IN CATH LAB
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84