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

Model Number	PED-475-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device and/or additional information a supplemental report will be filed.Related mdrs for this event: 2029214-2018-01027, 2029214-2018-01028.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this reported pipeline flex pushwire broke during the procedure.The patient was undergoing flow diversion of an unruptured a medium size unruptured saccular aneurysm located in cavernous segment in right internal carotid artery.The vessel was observed moderately tortuous.It was reported that the physician tried to deliver this pipeline through non-medtronic catheter but unable to delivered through the catheter and the pushwire broke on pipeline.The pipeline was removed from the patient and no harm or device was left in patient.The physician then exchanged for a medtronic catheter and successfully deployed third pipeline and completed the procedure.There were no reports of patient injury in association with this event.

• 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: 8142046
• Report Number: 2029214-2018-01028
• Device Sequence Number: 949883
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 12/07/2018

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: 10/28/2019
• Device Model Number: PED-475-30
• Device Lot Number: A367476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1