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

Model Number PED-400-35

Device Problems Retraction Problem (1536); Physical Resistance (2578); Activation Failure (3270)

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

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be received.Once the device has been received and analyzed a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that during a flow diverter case of an aneurysm in the right ophthalmic segment internal carotid artery (ica) aneurysm of 11x12mm with very tortuous ica.The flow diverter device failed to open at the distal section.The device was then attempted to be resheath the device, but the device was unable to be retrieve into the microcatheter.The catheter and the flow diverter device were removed together.The treatment plan was reconsidered, because of the tortuosity of the vessel, and the aneurysm was coiled.No patient injury occurred.The right internal carotid artery (ica) aneurysm was unruptured, saccular, with 11mmx12mm max diameter and a 4mm neck.The distal landing zone was 3.1mm, and the proximal was 3.8mm.The access vessel was 5mm.The blood flow was normal.

Manufacturer Narrative

The pipeline flex delivery system was returned for analysis.The system was found stuck within the distal segment of the catheter.The pipeline flex delivery system was then pushed out from the catheter lumen with difficulty.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was found to be bent near the proximal end.The distal and proximal ends of the pipeline flex braid were found fully opened with no damage.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bu mper.No other anomalies were observed.Based on the analysis findings and the event descriptions, the report of failure to open at the distal end could not be confirmed, as the returned pipeline flex was found fully opened with no damage.Possible contributing factor of "failure to open" include severe vessel tortuosity.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.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.¿ all products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE
• 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 ; 9492753836
• MDR Report Key: 7268390
• MDR Text Key: 100043767
• Report Number: 2029214-2018-00106
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-400-35
• Device Lot Number: A410147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR
• Patient Weight: 55