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

Model Number	PED-425-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it was discarded at the site.This device was used off-label to treat a ruptured aneurysm located in the left vertebral artery.Since the device was returned, the complaint of failure to open could not be confirmed, and the event cause could not be determined.It is possible that the patient¿s moderate vessel tortuosity may have contributed to the reported issue.Per our instructions for use (ifu): the user should begin to deliver the device using a combination of unsheathing the embolization device and pushing delivery wire simultaneously.After the distal end of the embolization device has successfully expanded, deploy the remainder of embolization device by pushing the delivery wire and/or unsheathing the 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 embolization device.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.The embolization device is intended for endovascular embolization of cerebral aneurysms.The embolization device should not be used alone as sole therapy for acutely ruptured aneurysms.
Event or Problem Description
Medtronic received information the that the flow diverter failed to open.The device was attempted to be deployed, however, the distal end was not fully opening.Resheathing was attempted once.More than 50% of the device failed to open.The device was removed and a new one was placed with out difficulty.The treating location was the vertebral artery.No patient injury occurred.The anatomy was reported to have been moderate in tortuosity.Pru level was 260 and is being monitored.The aneurysm was ruptured, pseudoaneurysm, with 10mm max and 7mm neck.The landing zone was 3.4mm x 4.2mm.
Additional Manufacturer Narrative
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: 6502477
• Report Number: 2029214-2017-00463
• Device Sequence Number: 802663
• Product Code: OUT
• UDI-Device Identifier: 00847536016200
• UDI-Public: 00847536016200
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

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: 10/12/2019
• Device Model Number: PED-425-20
• Device Lot Number: A358487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 76