MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOL. DEVICE 4.50MM X; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-71450-30

Device Problem Positioning Failure (1158)

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

Event Date 04/11/2016

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the internal carotid artery, the "head" of the pipeline device was fixed in the capture coil and could not be released.The push wire was rotated several times, but not more than the recommended 10 times.The physician used a new device to complete the procedure successfully.No patient injury was reported.

Manufacturer Narrative

Suspect medical device: added lot number the pipeline pushwire and braid were returned for evaluation.The tip coil was observed to be stretched, and the capture coil was observed to be damaged.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 both ends having slight fraying, and the middle section having no damage.Based on the analysis findings, the clinical observation could not be confirmed.We are unable to definitively determine the cause of the reported event or damages observed.Per the instructions for use: ¿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.A review of this device lot history record was conducted and no issues were identified that could have contributed to this event.All products are 100% inspected for damage and irregularities during manufacture.

• Brand Name: PIPELINE EMBOL. DEVICE 4.50MM X
• 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: 5674137
• MDR Text Key: 45747596
• Report Number: 2029214-2016-00338
• 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
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-71450-30
• Device Lot Number: A193900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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