MAUDE Adverse Event Report: COVIDIEN PIPELINE EMBOLIZATION DEVICE; FLOW DIVERSION

Model Number FA-77475-14

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

Treatment of an aneurysm located in the ophthalmic segment of the ica.The patient¿s anatomy was tortuous.On (b)(6) 2014, the patient underwent pipeline embolization treatment involving three pipelines.During the procedure, the first pipeline (4.75mm x 14mm) could not be released from the capture coil and ti was removed from the patient by trapping the pipeline braid between the capture coil and catheter.The second pipeline (4.75mm x 14mm) also could not be released from the capture coil and was also removed by the same method.Upon pulling the second pipeline out, the capture coil was found separated from the pushwire within the catheter.The third pipeline (5mm x 12mm) also had the same issues and was removed from the patient with the same method.The procedure was aborted.The patient was reported to be doing well at the end of the procedure.Same event as mdr# 2029214-2014-00723 and 2029214-2014-00724.

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no issues were noted that would have contributed to this event.The device will not be returned for analysis as it was discarded; therefore, the event cause could not be determined.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: FLOW DIVERSION
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4327030
• MDR Text Key: 5255738
• Report Number: 2029214-2014-00722
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2015
• Device Model Number: FA-77475-14
• Device Lot Number: 9664992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1