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

Model Number PED-325-16

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

The pipeline flex braid remains implanted in the patient; the pipeline flex delivery system has not been returned for evaluation.The delivery system was not returned, therefore the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pipeline flex device tip coil detached from the pushwire after the pipeline was deployed during a flow diversion procedure.It was reported that the procedure was uneventful prior to this.The pipeline was deployed and was well opposed to the carotid artery wall.Upon withdrawal of the pipeline flex, the tip coil remained in the patient's middle cerebral artery.A snare device was used to remove the tip coil from the patient.After removal, the tip coil was observed to have unraveled.No patient injury reported.

Manufacturer Narrative

Additional information received from medwatch form mw5072655.If information is provided in the future, a supplemental report will be issued.

Event Description

A snare device was used to remove the tip coil from the patient's middle cerebral artery.The tip coil was captured and pulled back smoothly.At the cavernous segment, the device was stuck at the tip of the intermediate catheter.When the physician was able to pull the device inside the intermediate catheter, it appeared some unraveled material of the pushwire was retained in the patient's cervical carotid artery.The material was reported as extremely tiny and not flow limiting or causing stenosis.

Manufacturer Narrative

The proximal segment of the pipeline flex pushwire was returned for evaluation.The pushwire appeared to be detached at the hypotube proximal to the wire weld.The distal hypotube appeared to be stretched.The pushwire was found to be bent at 33.0 cm from the proximal end.No other anomalies were observed.The surface (weld) of the detached pushwire was then sent out for scanning electron microscopy(sem) and electron dispersion spectroscopy(eds) analyses.Based on the reported event details, the analysis findings and the sem/eds analyses, the customer's report of ¿pushwire separation¿ was confirmed as the received pushwire was found to be detached at the hypotube proximal to the wire weld.The damages seen on the returned proximal wire (bending) and hypotube (stretching) were consistent with high forced used (pushing and pulling).It is possible the ¿severe vessel tortuosity¿ may have contributed to the high force used during procedure; subsequently causing the distal hypotube to stretch and then to separate.The review of device history record shows that the finished device met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damage and irregularities during manufacture.Per instructions for use: ¿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 intraluminal 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.¿ if information is provided in the future, a supplemental report will be issued.

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
• MDR Report Key: 6939196
• MDR Text Key: 90088344
• Report Number: 2029214-2017-01130
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PED-325-16
• Device Lot Number: A210313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other