MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-77450-20

Device Problem Positioning Failure (1158)

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

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that during treatment of a giant aneurysm located in the right cavernous sinus, the device could not be released from the capture coil.It was reported that the physician rotated the pushwire 8-10 times in effort to release the device but was unsuccessful and the device could not be positioned in the lesion.The device was retracted and another device was attempted; the second device encountered the same problem as the patient was reported to have severe vessel tortuosity.A third device was used and deployed successfully.No patient injury was reported.

Manufacturer Narrative

Additional information: information received from the same report as mfr: 2029214-2016-00045.

Manufacturer Narrative

The pipeline braid and pushwire were returned for evaluation.In addition, a torque device was observed to be attached to the proximal end of the pushwire.The torque device was removed from the pushwire with no issues.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was observed to be fully open, with one end having slight fraying, and the other end having severe fraying.No damages were found on the tip coil, capture coil, and proximal bumper.Based on the analysis findings the clinical observation was not confirmed.The cause for the reported experience could not be deter mined as the returned pipeline braid was observed to be detached from the pushwire.It is possible that the severe vessel tortuosity may have contributed to the reported issue.However, the cause for the damage to the pipeline braid could not be determined.Per the instructions for use (ifu): ¿if the capture coil tip of the delivery system becomes stuck in the mesh of a delivered ped, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ all devices are 100% inspected for damage and irregularities during the manufacturing process.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5389803
• MDR Text Key: 36805457
• Report Number: 2029214-2016-00044
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2017
• Device Model Number: FA-77450-20
• Device Catalogue Number: FA-77450-20
• Device Lot Number: 9961899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1