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

Model Number UNKNOWN

Device Problems Break (1069); Physical Resistance (2578)

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

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex was returned still stuck within the marksman catheter; however, the devices were separated with the distal part of the pipeline flex (pushwire and braid) stuck inside the distal part of the catheter (approximately 22.5cm) and the proximal broken pipeline flex pushwire was stuck inside the proximal broken catheter segment.The total length of the marksman catheter was measured and it was found to be within specifications.The pipeline braid was observed to be partially deployed from the broken end of the distal segment of the marksman catheter.Slight catheter accordion was observed at near the distal tip.The broken end of the distal segment of the marksman catheter was observed to have its braid exposed at 22.5cm from the distal tip.The broken distal and proximal catheter segments had to be dissected to remove the pipeline broken segments from them.The broken end of the proximal segment of the marksman catheter was observed to have its braid exposed and catheter accordion was observed at several locations.Kink was observed near the broken end of the proximal catheter segment.No flash, voids molded, or damages were observed on the catheter hub.Due to the damaged condition of the marksman catheter, the marksman catheter could not be further tested.Please refer to mdr# 2029214-2017-00932 for the marksman catheter.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during embolization treatment of an unruptured saccular aneurysm measuring 4.5mm located in the left ica (internal carotid artery), the physician felt resistance in the distal section of the marksman catheter as they were trying to deploy the pipeline flex after it was re-sheathed.The pipeline flex became stuck and another pipeline flex and marksman catheter was used to complete the procedure.The vessel was normal in tortuosity and 5mm in diameter.The patient was on dual antiplatelet therapy and there was no patient injury reported.

Manufacturer Narrative

The device was made reportable based on the condition of the returned device.Device code updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during embolization treatment of an unruptured saccular aneurysm measuring 4.5mm located in the left ica (internal carotid artery), the physician felt resistance in the distal section of the marksman catheter as they were trying to deploy the pipeline flex after it was re-sheathed.The pipeline flex became stuck and another pipeline flex and marksman catheter was used to complete the procedure.The vessel was normal in tortuosity and 5mm in diameter.The patient was on dual antiplatelet therapy and there was no patient injury reported.Based on the returned, device evaluation found the pipeline flex device was separated from the distal end.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6757925
• MDR Text Key: 81590391
• Report Number: 2029214-2017-00933
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR