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

Model Number	PED-450-35
Medical Device Problem Codes	Physical Resistance (2578); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The flow diverter was found stuck within the distal segment of the catheter.Approximately 1.0 cm of the tip coil was found partially deployed outside of the catheter tip; and the remaining segment of the tip coil along with the flow diverter was inside distal segment of the catheter.It is possible that the severe vessel tortuosity may have contributed to the reported; subsequently causing the device to become damaged and stuck within the catheter.Based on the condition of the returned device, it appears that excessive force was used.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 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.
Event or Problem Description
Medtronic received report that during the cerebral aneurysm, size: 18mm / flow diversion procedure, the physician delivered the flow diverter through the microcatheter, and tried to open the flow diverter.However, the tip of the flow diverter did not open.The flow diverter was also reported to have become stuck and only 10mm to 15mm of the flow diverter was deployed from the microcatheter, and the rest could not be push out.New devices were used to complete the procedure.The anatomy was slightly severe and the vessel was medium in size diameter.No patient injury occurred.
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: 6429551
• Report Number: 2029214-2017-00213
• Device Sequence Number: 602689
• Product Code: OUT
• UDI-Device Identifier: 00847536016569
• UDI-Public: 00847536016569
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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: 04/05/2019
• Device Model Number: PED-450-35
• Device Lot Number: A255715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/23/2017
• 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
• Patient Age: 65 YR