MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-71500-30

Device Problem Malposition of Device (2616)

Patient Problem Death (1802)

Event Date 03/06/2015

Event Type  Death  

Event Description

Medtronic (covidien) received information that during a flow diversion treatment of a left large saccular unruptured carotid cavernous aneurysm, the physician reported that the pipeline was deployed but the proximal portion of the ped curled into the aneurysm.It was reported that the pipeline was implanted at the targeted location with no friction during delivery.The physician attempted to perform angioplasty to expand/appose to vessel wall.While attempting angioplasty the proximal end of the pipeline foreshortened into the aneurysm.The physician attempted to correct the issue via few maneuvers using alligator retrieval device, balloons, wire and guide catheter, however, these maneuvers were unsuccessful.Therefore, the proximal portion of the ped is within the aneurysm.The patient died 9 days post procedure from left hemisphere stroke.

Manufacturer Narrative

The pipeline was not returned for analysis as it was implanted in the patient; therefore, the event causes could not be determined.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.No other complaints have been reported against the lot number.The event occurred in the patient post procedure and its cause was unknown.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618
• MDR Report Key: 4659704
• MDR Text Key: 21474308
• Report Number: 2029214-2015-00345
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S004
• 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: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2017
• Device Model Number: FA-71500-30
• Device Lot Number: A034997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Date Device Manufactured: 09/22/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 74 YR