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

Model Number FA-77450-16

Device Problem Positioning Failure (1158)

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

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.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 an aneurysm, the device was prepared to release, however the physician found that "head" of the device could not be opened.The physician made adjustments however was unsuccessful.A new device was used to complete the surgery successfully.No patient injury was reported.

Manufacturer Narrative

The pipeline pushwire was returned for evaluation within a dispenser coil.The pipeline braid was not returned for evaluation.The pushwire within the capture coil was observed to be bent.The capture coil was observed to be damaged.Pushwire bends were also observed.The lot history record of the reported lot number has been reviewed and no quality issues were noted.Based on the analysis findings the clinical observation could not be confirmed.The pipeline braid was not returned for evaluation; therefore any contributing factors from the pipeline braid could not be assessed.The cause for the reported experience could not be determined.It is possible that the damaged capture coil and pushwire may have contributed to the reported issue; subsequently preventing the braid from releasing from the capture coil.However, the cause for the damages could not be determined.Per our instructions for use (ifu): ¿detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system.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.Never rotate the delivery wire more than 10 full turns.If ped does not open after 10 turns, remove the entire system (microcatheter and ped delivery system together).¿ all products are 100% inspected for damage and irregularities during manufacture.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 5973654
• MDR Text Key: 55482393
• Report Number: 2029214-2016-00827
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2017
• Device Model Number: FA-77450-16
• Device Lot Number: 9963792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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