MAUDE Adverse Event Report: ABBOTT JOSTENT GRAFTMASTER OTW

Model Number GCG1240UA

Device Problem Premature Activation (1484)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/08/2010

Event Type  Death  

Event Description

The patient underwent planned left main coronary intervention on (b)(6) 2010, having undergone diagnostic coronary angiography at another hospital several days earlier.During the coronary intervention, following deployment of two drug eluting stents to reconstruct the left main bifurcation, the patient sustained a perforation of the left main coronary artery, associated with hemodynamic collapse.Vasopressor therapy was begun and subxiphoid pericardiocentesis was performed to drain the hemopericardium.Due to ongoing hemorrhage from the left main coronary artery, the stent loosened from its deployment balloon and embolized to the mid portion of the left anterior descending artery.A second graftmaster stent was then advanced and deployed in the left main coronary artery, but the patient became asystolic nonetheless, and expired.At the time of the event, the manufacturer was notified and the manufacturer submitted a full report to the fda.I was made aware of this adverse event on january 24, 2016, following an internal audit of this protocol's activity.

• Brand Name: JOSTENT GRAFTMASTER OTW
• Type of Device: GRAFTMASTER
• Manufacturer (Section D): ABBOTT ; rodolf-dielel-strasse 29; rangendingen D7241 4; GM D72414
• MDR Report Key: 5445055
• MDR Text Key: 38536946
• Report Number: 5445055
• Device Sequence Number: 0
• Product Code: MAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GCG1240UA
• Device Lot Number: 579477
• 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: 02/01/2016
• Distributor Facility Aware Date: 01/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2010
• 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): Death
• Patient Age: 83 YR
• Patient Weight: 66