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

Model Number	PED2-500-35
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding difficulty retrieving/resheathing the pipeline shield with the phenom 27 microcatheter and the pipeline was dislodged from the delivery system.The patient was undergoing a procedure for flow diversion stent embolization of a c4 cavernous sinus segment lateral wall unruptured saccular aneurysm via femoral access.The aneurysm max diameter was 6mm and the neck diameter was 6mm.Patient vessel tortuosity was minimal.It was reported that the devices were prepared and the catheter was flushed per the instructions for use (ifu).The phenom 27 microcatheter was delivered to the treatment location and the pipeline was delivered.The distal end of the pipeline was opened in the m1 straight segment.Then it was pulled back to the proximal positioned of the anterior choroidal artery.When releasing in the c6 segment, it was found that the pipeline could not but fully opened and the device was not anchoring well to the vessel wall.After deploying a sufficient distance and attempting to swing the device back and forth to coax open, the issue still did not resolve.The surgeon then attempted to retrieve the pipeline and redeploy.However, the pipeline could not be retrieved smoothly and, after several attempts, the surgeon retrieved both the pipeline and the phenom 27 microcatheter with the intermediate catheter.Once removed from the patient's body, it was found that the pipeline had dislodged from the delivery pusher.The surgeon replaced the pipeline with a pipeline 4.75 x 35 and the procedure was completed successfully.There was no harm or injury to the patient.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 227716241); product type: ; implant date n/a; explant date n/a 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
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 the resistance appeared at the distal end of the catheter.No damage to the pipeline pushwire or catheter was observed.The middle section of the pipeline did not open.The pipeline had been placed in a vessel bend when it failed to open.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgsfg15xxx-yyyy rev.F as found condition: the pipeline flex shield was returned inside the phenom 27 catheter, a sealed bio-hazard bag, and a shipping box.Damage location details: the tip coil is in good condition.The distal and proximal dps restraints and dps sleeves were found to be intact, with no signs of damage.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube and ptfe shrink tube were intact, with no signs of elongation and damage.The braid's distal, middle, and proximal parts were fully opened without damage.No bends were found on the pushwire.The catheter tip and marker were examined, and no damages were noted.The catheter body was found to be accordioned at 6.0cm to 10.4cm from the distal tip.No other anomalies were observed.Testing/analysis: the pipeline flex shield was pushed from the catheter lumen.The total and usable length of the catheter were measured within specifications.The catheter was flushed with water and found patent.The catheter was tested by running an in-house 0.026¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub without resistance; however, resistance was observed at damaged locations.Conclusion: based on the reported information and device analysis, the customer¿s report of ¿failure/incomplete open at the middle¿ was not confirmed, as the braid¿s distal, middle, and proximal were found fully opened with no damage.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity and the user deploying the braid in the vessel bend.The customer reported that the vessel tortuosity was minimal, ruling out the vessel tortuosity as a potential cause.In this event, the customer stated that the device was placed in a vessel bend, which may have contributed to the ¿failure/incomplete open¿ complaint.However, the cause of the ¿failure/incomplete open¿ could not be determined.In addition, the pipeline flex shield was returned inside the phenom catheter.The phenom catheter was damaged.From the damage noted on the catheter (accordioning), it appeared that a high force was used.The damage may have occurred when the customer attempted to advance/retrieve the pipeline flex shield through the catheter against resistance.However, the cause of the resistance could not be determined.Possible resistance causes include a lack of continuous flush with heparinized saline during the procedure.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: 19794315
• Report Number: 2029214-2024-01277
• Device Sequence Number: 11798670
• Product Code: OUT
• UDI-Device Identifier: 00763000284756
• UDI-Public: 00763000284756
• 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): 10/23/2024

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 Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B699523
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 10/01/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/07/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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