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

Model Number FA-71375-30

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information that during the treatment of fusiform, unruptured, right middle cerebral artery (mca) m1 segment aneurysm with a pipeline embolization device (ped), the ped failed to open completely.It was reported that the aneurysm neck length was 15mm and the ped landing zone was at distal m1 segment of the mca artery.It was reported that the proximal end of the pipeline did not open completely and it remained in a cone shape.Many attempts were made to open the device.The physician tried passing a micro catheter across the device to open the pipeline with a balloon, this was unsuccessful.Then the physician used a snare to try to remove the device, but this attempt was also unsuccessful.The device was implanted and the patient was not injured.Post procedure, patient was put on low dose of aspirin and ticagrelor.

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 implanted in the patient; therefore, the event cause could not be determined.(b)(4).

• Brand Name: PIPELINE EMBOLIZATIN 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: 9775 toledo way; irvine, CA 92618 ; 9492975480
• MDR Report Key: 4519418
• MDR Text Key: 5489902
• Report Number: 2029214-2015-00147
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2016
• Device Model Number: FA-71375-30
• Device Lot Number: 9844767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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 Age: 23 YR