MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-14

Device Problem Break (1069)

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

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline device remains implanted in the patient.The pushwire (pipeline delivery system) has not been received for evaluation.The cause of the event could not be conclusively determined from the reported information.Should the product be received for analysis, additional information will be provided in a supplemental report.

Event Description

Medtronic received information that a pipeline flex device tip coil fractured after the braid had been deployed during a flow diversion procedure.The device was used to treat the patient's cerebral aneurysm at the internal carotid artery.It had max diameter of 12mm and neck width of 6mm.Vessel tortuosity was not available.It was reported the device was prepared as indicated in the instruction for use.The microcatheter was flushed continuously with heparinized saline during the procedure.No resistance was met during the pipeline delivery.There was also no issue deploying the pipeline.The pipeline was never resheathed.The tip coil of the pushwire broke while it was being captured by the microcatheter.The entire delivery system, (including the fractured tip coil) was retrieved.No injury reported.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN, IRVINE; 9775 toledo way; irvine CA
• Manufacturer (Section G): COVIDIEN, IRVINE; 9775 toledo way; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7107244
• MDR Text Key: 94658826
• Report Number: 2029214-2017-01338
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: PED-400-14
• Device Catalogue Number: PED-400-14
• Device Lot Number: A506062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Date Device Manufactured: 08/10/2017
• 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