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

Model Number FA-71400-35

Device Problems Flaked (1246); Activation Failure (3270)

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

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned as it remains in the patient.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.

Event Description

Medtronic received information that during treatment of an aneurysm located in the right side of the intracavernous internal carotid artery the middle segment of the device did not open.It was reported that the microcatheter reached to 20 mm of the neck of the aneurysm and the distal segment opened successfully however, as the physician released the device slowly a mild "kink" in the middle of the device was noted.The physician then repeated to increase and release tension but it did not reach the device to release the rest of the device.The device had good wall apposition and the physician pushed the guidewire, however the "kink" within the middle of the device could not be opened and remains in the patient.No patient injury was reported.

Manufacturer Narrative

The pipeline pushwire was returned within the microcatheter.The pipeline braid was not returned for evaluation as it was implanted in the patient.The pipeline pushwire was observed to be within a microcatheter with an rhv attached to the microcatheter hub and a torque device attached to the proximal section of the pipeline pushwire.The torque device and rhv were removed from the microcatheter and pipeline pushwire with no issues.For further examination, the pipeline pushwire was pushed through the microcatheter with no issues.Based on the analysis findings the clinical observation could not be confirmed as the pipeline braid was not returned.Therefore, we are unable to definitively determine the cause for the reported experience.A review of this device lot history record was conducted and no issues were identified that could have contributed to this event.In addition, ancillary findings not related to this event were observed during analysis.Coating damage was observed on the pushwire at 62.0cm from the distal tip coil, and 28.0cm to 30.0cm from the proximal end.We are unable to definitively determine the cause of the coating damage observed.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: 5645650
• MDR Text Key: 44889830
• Report Number: 2029214-2016-00290
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/22/2019
• Device Model Number: FA-71400-35
• Device Lot Number: A216381
• 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: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2016
• 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
• Patient Age: 52 YR