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

Model Number FA-77275-20

Device Problem Positioning Failure (1158)

Patient Problem Vascular Dissection (3160)

Event Date 08/31/2016

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.Follow up is being performed.If the device or additional information should be received, a supplemental will be submitted.

Event Description

Medtronic received information that during treatment of an aneurysm, after radiography m2 segment of the internal carotid artery (ica) dissection was observed.The origin of the dissection is unknown at this time.It was further reported that the physician found the "head" of the device could not be opened, the physician made adjustments but failed and the pipeline was removed.The surgery was completed using coils.No patient injury was reported.

Manufacturer Narrative

The pipeline was returned within the microcatheter.The pipeline braid was observed to be partially deployed approximately 1.0 cm and released from the capture coil.For further examination, the pipeline delivery system was pushed out of the catheter with no issues.The pipeline braid was observed to be fully open with dried blood with the distal end having slight fraying, and the middle section and proximal end having no damages.Pushwire was also observed bent.No damages were found on the tip coil.No other anomalies were 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.The patient anatomy condition was not reported; therefore any contributing factors from the patient anatomy could not be assessed.It is possible that the ¿damaged braid¿ may have contributed to the reported issue.In addition, damages seen on the pushwire (bending) and catheter body (flattening / kinking); appears there was excessive force used.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.Rotate the delivery wire only in a clockwise direction.Rotating in a counter-clockwise direction may make device release more difficult or impossible.If high force or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.¿ 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.

Manufacturer Narrative

Correction: no remedial action was initiated due to inspection.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: 5991140
• MDR Text Key: 56105366
• Report Number: 2029214-2016-00846
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2018
• Device Model Number: FA-77275-20
• Device Lot Number: A156155
• 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: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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