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

Model Number FA-71425-35

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 and microcatheter were returned for evaluation.The pipeline braid was observed to be partially deployed from the catheter tip for 1.5cm 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 capture coil was observed to be compressed.The pipeline braid was observed to be fully open, with both ends having slight fraying.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 fully opened, and observed to be released from the capture coil.It is possible that the damaged braid (fraying) may have contributed to the reported issue.In addition, damage was found on the pushwire (bending).However, the cause for the damages could not be determined.All devices are 100% inspected for damage and irregularities during the manufacturing process.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.

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: 5811038
• MDR Text Key: 50076175
• Report Number: 2029214-2016-00598
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Model Number: FA-71425-35
• Device Lot Number: A214783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided; 09/14/2016
• Supplement Dates FDA Received: 09/27/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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