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

Model Number PED-450-25

Device Problem Break (1069)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex was returned with a microcatheter.As received, the pipeline flex pushwire was within the proximal segment of the microcatheter.The pushwire was observed to be stuck within the catheter; it could not be pushed forward or pulled back.For further examination, the microcatheter was dissected at several locations to remove the pushwire.The tip coil was observed to be detached and missing from the dps sleeves.Pushwire separation was observed approximately 209cm from the proximal end.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Pushwire bends were observed at a section near the proximal end.The pipeline flex braid was not attached to the pushwire; the distal and proximal ends of the braid were unable to be identified.The braid was observed to be fully open with slight fraying on both ends.Based on the analysis findings, it appears that the complaints against the pipeline flex are in regards to resistance, pushwire separation, and pushwire kink damage.Based on sem analysis, the mechanism for the pushwire separation of the pipeline flex delivery system could not be determined as no original fracture features are visible on the fracture surface.The pushwire of the pipeline flex delivery system was possibly separated due to tensile failure.However, the circumstances under which this device was used were not reported; the cause of the observed damage cannot be conclusively determined.All products are 100% inspected for damage and irregularities during manufacture.The damage observed suggest that excessive force was used (pushing and pulling).Per our instructions for use (ifu): ¿if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously.Advancement of the pipeline flex embolization device against resistance may result in damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.¿ mdrs related to this event: 3012113714-2017-00004, 2029214-2017-01114.

Event Description

Medtronic received a returned pipeline flex and microcatheter without any event information.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6921256
• MDR Text Key: 89936574
• Report Number: 2029214-2017-01114
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: PED-450-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1