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

Model Number PED-500-35

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it was discarded by the customer.The device 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.

Event Description

Medtronic received report of pipeline flex did not open during a procedure.The patient was undergoing treatment for an unruptured aneurysm located in the right cavernous internal carotid artery (ica).The aneurysm measured 25mm and the vessel diameter was approximately 5mm.The vessel tortuosity was slightly severe.The devices were prepared as indicated in the ifu.It was reported that a pipeline flex was deployed and did not open.The physician attempted to "spread and resheath" the device a few times, but the pipeline flex and catheter became stuck near the aneurysm neck.The physician suspected that the devices were damaged and removed them from the guide catheter.Afterward, a new pipeline flex was able to be implanted in the desired location.There were no reports of patient injury in connection with this event.The patient is currently fine.

Manufacturer Narrative

The pipeline flex pushwire was returned for evaluation with the catheter.As received, approximately 14.5 cm of the distal segment of the pipeline flex pushwire was deployed outside of the catheter tip.The remainder of the pushwire was found stuck inside the distal segment of the catheter.The pipeline flex braid was not returned.For further examination, the pipeline flex pushwire was pushed out of the catheter lumen with difficulty.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire approximately 37 to 42.5 cm from the proximal end.Based on the analysis findings and event description, the report of pipeline flex failure to open could not be confirmed as the braid was not returned for evaluation.It¿s possible that the patient's vessel tortuosity may have contributed to the reported issue.The report of resheathing resistance was confirmed as the received pipeline flex pushwire was found stuck inside the distal segment of the catheter.However, the cause for resistance could not be determined.Additionally, the damage observed on the proximal wire (bending) and hypotube (stretching) suggest that excessive force used.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu), the user should ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.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: 5998016
• MDR Text Key: 56449579
• Report Number: 2029214-2016-00865
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• 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: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2019
• Device Model Number: PED-500-35
• Device Lot Number: A295473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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