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

Model Number PED-475-30

Device Problem Break (1069)

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

Event Date 11/13/2018

Event Type  malfunction  

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 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
• 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 ; 9498373700
• MDR Report Key: 8142046
• MDR Text Key: 129782745
• Report Number: 2029214-2018-01028
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: PED-475-30
• Device Lot Number: A367476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2016
• 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