MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number	PED2-500-30
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a pipeline shield stent that failed to open.  the patient was undergoing a procedure for flow diverter treatment of an m1 segment unruptured saccular aneurysm.The aneurysm max diameter was 6mm and the neck diameter was 4mm.Vessel tortuosity was moderate.It was noted that dual antiplatelet treatment was not administered.It was reported that the pipeline and all accessory devices were prepared per the instructions for use (ifu).The pipeline failed to open at the distal end when less than 50% of the pipeline had been deployed.The pipeline was not positioned in a bend.The pipeline was reseheathed and removed with the microcatheter.  ancillary devices: 8f terumo sheath, wallant 6f 088 guide catheter, phenom 27 microcatheter, hybrid 014 guidewire, phenom plus catheter there was no harm or injury to the patient.Post-procedure angiography showed satisfactory redirected blood flow from the aneurysm.The event did not lead to or prolong the patient's hospitalization. no additional medication or surgical intervention was required to prevent permanent patient impairment.
Additional Manufacturer Narrative
Product analysis: the pushwire was extending out from catheter hub.The distal hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.The distal end of pipeline flex shield braid was found to be not opened due to damaged braid.The proximal end of pipeline flex shield braid was found to be fully opened and damaged.The catheter body was found to be kinked at ~60.0cm from distal end.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: LASER THERAPY PRODUCT
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19950656
• Report Number: 2029214-2024-01402
• Device Sequence Number: 15688815
• Product Code: OUT
• UDI-Device Identifier: 00763000284749
• UDI-Public: 00763000284749
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 08/14/2026
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B611129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Female