MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-18

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex braid remains implanted in the patient; the pipeline flex delivery wire has not been returned for evaluation.The reported event could not be confirmed.An event cause could not be conclusively determined from the reported information.

Event Description

Medtronic received report of pipeline flex delivery wire separation during a procedure.The patient was undergoing treatment for an unruptured, amorphous aneurysm in the left internal carotid artery (ica).The aneurysm max.Diameter was 11.5mm and neck diameter was 4.5mm.The landing zone artery size was 2.72mm distal and 4.13mm proximal.The vessel tortuosity was moderate.The devices were prepared as indicated in the ifu.It was reported that the pipeline flex was delivered without issue.The pipeline flex delivery wire was recaptured into the microcatheter.While removing the delivery catheter and delivery wire as a system through the rhv attached to the guide catheter, the wire reportedly separated into two pieces at the distal end.The separation reportedly occurred at the hypotube proximal to the wire weld.There were no reports of patient injury in connection with this event.

Manufacturer Narrative

Additional information, device evaluation: the pipeline flex pushwire was returned for evaluation with the catheter.As received, the pipeline flex pushwire was found outside of the catheter.The pipeline flex braid was not returned as it was implanted in the patient.It appeared that the pipeline flex pushwire was detached at the hypotube proximal to the wire weld.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire approximately 35.5 cm and 41.5 cm from the proximal end.The surfaces of the detached pushwire were then sent out for scanning electron micrographic (sem) and energy dispersive spectroscopy (eds) analysis.Based on the reported event details and analysis findings, the report of pushwire detachment at the hypotube proximal to the wire weld was confirmed.The distal wire of the pipeline flex delivery system was possibly detached due to tensile failure.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation are well defined and documented appropriately in the associated manufacturing procedures.The elemental analysis conducted through sem and eds showed indicated that the soldering was conducted.In addition, the lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.All products are 100% inspected for damage and irregularities during manufacture.It is possible that the ¿moderate vessel tortuosity¿ may have contributed to the detachment issue, subsequently causing the device to become damaged.Additionally, the damages seen on the catheter body (flattening/accordioning), proximal wire (kinking/bending) and hypotube (stretching) suggest that excessive forced used.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6082717
• MDR Text Key: 59350438
• Report Number: 2029214-2016-00980
• 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: 10/12/2016

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: 10/29/2018
• Device Model Number: PED-400-18
• Device Lot Number: A181201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided; 11/16/2016
• Supplement Dates FDA Received: 12/06/2016; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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 Age: 72 YR
• Patient Weight: 67