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

Model Number	PED-475-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.However, the device evaluation has yet not began.Supplemental report will be submitted upon completion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the pipeline failed to open and was damaged at the distal section.The pipeline and the catheter were removed as a system.The patient was being treated for an unruptured, left pcom aneurysm, that was saccular.The max diameter was 11 mm with a neck width of 4.5mm.The distal landing zone was 4.82mm and the proximal was 4.32mm.The anatomy was moderate in tortuosity.There was no patient injury reported.The devices were all used per the ifu.The pipeline was reported to have been placed on a bend and the device failed to open at the distal section of the treating vessel.Less than 50% was deployed when the device failed to open.The pipeline resheathed less than or equal to 2 times.
Additional Manufacturer Narrative
Corrected udi number.The pipeline flex was returned for analysis.The device found to be stuck within the distal segment of the microcatheter.The pipeline flex delivery system could not be pushed forward or removed.For further examination, the microcatheter was cut to remove the pipeline flex.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 distal and proximal ends of the pipeline flex braid were found fully opened with moderately frayed.The pushwire appeared to be kinked at near the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.Based on the analysis findings and the event descriptions, the reports of failure to open at the distal end issue, the report could not be confirmed as the returned pipeline flex braid was found fully opened with moderately frayed at both ends.Possible causes include the patient¿s vessel tortuosity and damaged braid.From the damages seen on the pipeline braid (fraying); proximal wire (kinking/bending) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when the reported attempted to advance the pipeline flex delivery system through the micro catheter against resistance.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is enco untered during delivery.Identify the cause of the resistance and remove device and micro catheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against res istance 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.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.Re-sheathing 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.¿ 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 FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 7476626
• Report Number: 2029214-2018-00357
• Device Sequence Number: 1769465
• Product Code: OUT
• UDI-Device Identifier: 00847536016651
• UDI-Public: 00847536016651
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2019
• Device Model Number: PED-475-14
• Device Lot Number: A345274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 04/07/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR