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

Model Number FA-71425-25

Device Problems Positioning Failure (1158); Activation Failure (3270)

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

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline device has not been returned for evaluation.The reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2016-00597 2029214-2016-00598 2029214-2016-00599.

Event Description

Medtronic received report that a pipeline device could not open or release during embolization of an aneurysm.The device was removed from the patient.There were no reports of patient injury in connection with this event.The patient is reportedly in stable condition.

Manufacturer Narrative

The pipeline, pushwire and microcatheter were returned for evaluation.The pipeline braid was observed to be partially deployed from the catheter tip for 1.0cm and released from the capture coil.For further examination, the pipeline pushwire was pushed out and the pipeline braid was deployed out of the microcatheter with no issues.The pushwire was observed to be bent within the capture coil.The pipeline braid was observed to be fully open, with the distal end having slight fraying.No damages were found on the tip coil, capture coil, and proximal bumper.In addition, flattening of the microcatheter was observed.Based on the analysis findings the clinical observation could not be confirmed.The cause for the reported experience could not be determined as the returned pipeline braid was observed to be released from the capture coil and fully opened.It is possible that the damaged braid (fraying) and the pushwire being ¿bent within the capture coil¿ may have contributed to the reported issue.However, the cause for the damages could not be determined.All devices are 100% inspected for damage and irregularities during the manufacturing process.

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: 5811037
• MDR Text Key: 50076095
• Report Number: 2029214-2016-00599
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2018
• Device Model Number: FA-71425-25
• Device Catalogue Number: FA-71425-25
• Device Lot Number: A197312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• 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: 43 YR