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

Model Number	PED2-500-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two pipelines failed to open and the first became stuck in the phenom 27 microcatheter during retrieval.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ophthalmic artery.The max diameter was 4mm, and the neck diameter was 4mm.The landing zone was 5mm, distal and 4mm proximal.The patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.It was reported that the tip of the pipeline could not be opened after it was pushed out of the catheter.It still did not open after repeated retrieval.The stent was then retrieved and removed from the body, but it got stuck at the proximal end of the catheter and could not be removed.A new catheter and pipeline were used.The stent was pushed out of the catheter after it was in place, but the stent tip still could not be opened.Repeated retrieval and adjustment of the deployment position were ineffective, so the stent was removed and the surgery was rescheduled.The patient did not experience any injury or complications.Angiographic results post procedure showed blood retention in the aneurysm.The devices were prepared and flushed according to the instructions for use (ifu).
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 227752626).Product id ped-500-16 (b724747).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
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 was received that there was no damage observed to the pipeline pushwire or catheter.The distal section of the pipeline did not open.The pipeline was placed in a straight section when it failed to open.The pipeline was retrieved several times and tried to retrieve the protective sheath in attempt to open the pipeline.The cause of the event was not determined.
Additional Manufacturer Narrative
H3: product analysis: as found condition: the pipeline flex shield embolization device and xt-27 catheter were returned for analysis within shipping box; and within a plastic bio-pouch.The pipeline flex shield pushwire was returned within the xt-27 catheter.Damage location details: the pushwire was extending out from xt-27 catheter hub.No bend was observed on the 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, pads or with the proximal bumper.The distal and proximal ends of pipeline flex shield braid were found to be fully opened and damaged.No damage was found with xt-27 catheter.No other anomalies were observed.Testing/analysis: the pipeline flex shield was pushed out from xt-27 catheter without any issue.Conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure /incomplete open at distal as the distal and proximal ends of pipeline flex shield braid were found fully opened and damaged.However, the root cause for damages could not be determined.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: 20349070
• Report Number: 2029214-2024-01730
• Device Sequence Number: 12776294
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: 00763000284718
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 12/18/2024

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: 07/25/2026
• Device Model Number: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: B601287
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/12/2024; 11/22/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: Unknown