MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number	FG15150-0615-1S
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nervous System Injury (2689)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that there was failure to open in the distal portion of the pipeline (lot b645491).The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.There was failure to open in the middle portion of the pipeline (lot b277254).The pipeline was not positioned in a bend.The pipeline was resheathed less than or equal to two times.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.No patient symptoms or further complications were reported as a result of this event.The pipeline was used for an approved indication.The device and any accessories were not prepared as indicated in the ifu.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level listed as no.No new information: from (b)(4) (rep, hcp, for): medtronic received a report that  in the course of securing a left carotid ophthalmic aneurysm, healthcare provider (hcp) attempted placement of the pipeline vantage stent.The operator noticed a deformation on the phenom 27 microcatheter and had difficulty repositioning the stent.After several attempts to place the pipeline, the stent and microcatheter were removed.The stent was secured by coiling without stenting.On awakening, the patient revealed a neurological deficit with progressive improvement.An emergency cerebral mri showed no ischemia and no post-operative hemorrhagic post-operative complications.
Additional Manufacturer Narrative
Report 9612164-2024-01103 was merged into (b)(4) from (b)(4).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
Additional information received reported they physician did report any patient adverse symptoms or injuries.No ongoing neurological deficit was noted.Recovery was normal and the patient underwent additional separate procedure to treat a different, unrelated aneurysm in a different vascular location.
Additional Manufacturer Narrative
B5 updated with additional information received.H6 coding updated based on all available information.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.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the pipeline vantage shield embolization device and phenom 27 catheter were returned for analysis within shipping box; and within a plastic bio-pouch.The pipeline vantage shield embolization device was returned within the phenom 27 catheter.¿ damage location details: the pushwire extending out from catheter hub.In addition, the partial distal braid, sleeves and tip coil were deployed from catheter distal tip.No bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, arms or with the proximal bumper.The distal and proximal ends of pipeline vantage shield braid were found to be fully opened and damaged.In addition, the middle section was found to be fully opened and no damaged.No flash or voids molded were observed in the hub.The catheter body was found to be accordion from ~5.5cm to ~3.2cm from distal end.No damage was found with the phenom 27 catheter distal marker/tip.No other anomalies were observed.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: PHENOM CATHETER
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 19391119
• Report Number: 9617601-2024-00087
• Device Sequence Number: 7799392
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151638
• 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,Followup,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2026
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 226990778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 05/26/2025
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/22/2024; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown