MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED2-425-20
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline tip was damaged.It was reported that the physician wanted to shape the tip coil.So on the back table they attempted to shape the tip.During the shaping the tip was damaged.Device was removed from sterile field and a new device was selected and implanted without incident.The pipeline was not used for an indication that is not approved (off-label).The pipeline and any accessory devices were not prepared as indicated in the ifu.
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicated a reportable event.Product analysis: equipment used: vis (m-81805), 203cm ruler (m-83360) as found condition: the phenom 27 catheter was returned for analysis within a shipping box and within an opened pipeline flex outer carton (b198085).Visual inspection/damage location details: no damage was found with the phenom 27 catheter hub.However, upon microscopic inspection, the pipeline flex braid was found within the catheter hub.No bends or kinks were found with the phenom 27 catheter body.No damages were found with the phenom 27 distal marker/tip.The phenom 27 catheter was dissected (cut) and the pipeline flex braid with the ptfe sleeves and tip coil were removed.The pusher was found broken proximal to the ptfe sleeves.The ptfe sleeves and tip coil were found damaged.Testing/analysis: the pipeline flex pusher distal core wire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via torsional overload.Conclusion: based on the device analysis and reported information, the customer¿s ¿pushwire kink/damage¿ report was confirmed as the tip coil was found damaged.It is likely some damage occurred during the tip shaping process.Regarding the broken pipeline flex pusher distal core wire, the investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation, pusher separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.As the core wire failed via torsional overload it is likely some excessive force was used.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13064147
• Report Number: 2029214-2021-01666
• Device Sequence Number: 14491306
• Product Code: OUT
• UDI-Device Identifier: 00763000284459
• UDI-Public: 00763000284459
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: 04/27/2024
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: B198085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown