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

Model Number PED-450-25

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation; return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information the distal tip of the pipeline flex (the tip coil) separated while in the internal carotid artery during attempted deployment of the pipeline flex to treat a saccular unruptured left internal carotid artery aneurysm.The device was not in a side branch at the time of separation.The pipeline flex was not implanted.The distal tip remained in the patient at the time of separation.A competitor device was used to complete the procedure.There were no reported patient symptoms related to this event.The catheter and the pipeline flex were reportedly prepared and used per the ifu instructions.It was further reported no resistance was encountered and the physician was not aware of the potential cause of the tip coil separation.Vessel tortuosity was reported as moderate.

Manufacturer Narrative

Device analysis confirmed the clinical observation of detached distal segment of the pipeline flex pushwire.The pipeline flex pushwire was detached at the hypotube proximal to the wire weld.The detached distal segment of the pushwire was not returned.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was observed to be bent at two locations.The distal end of the hypotube was sent for sem (scanning electron microscope) and eds (energy dispersive spectroscopy) analyses.The analyses confirmed presence of soldering material.The lot history record of the reported lot number was reviewed and no quality issues were identified that would have contributed to this event.Damages noted on the returned device suggest the detachment occurred due to tensile failure.This type of damage has been seen in cases with significant vessel tortuosity.In this case, a moderate amount of tortuosity was noted.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine,ca
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine,ca
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5924509
• MDR Text Key: 53806428
• Report Number: 2029214-2016-00767
• 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,Followup,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2018
• Device Model Number: PED-450-25
• Device Lot Number: A076064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided; 09/15/2016
• Supplement Dates FDA Received: 09/30/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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 Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 79