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

Model Number	PED2-500-16
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received reported that no damage to the pipeline pushwire or catheter was observed.The pipeline had not been placed in a vessel bend when it failed to open.Multiple retrieval attempts were made to open the pipeline.The pipeline was resheathed 3 times.
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.
Additional Manufacturer Narrative
H3: the pipeline flex shield was returned stuck inside the phenom 27 catheter.The distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The braid's distal end was not opened due to the damaged braid.The proximal end of the braid was opened and frayed.Bends were found at 15.0cm to 36.5cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body was found to be accordioned at 6.7cm to 15.3cm from the distal tip.No other anomalies were observed.The catheter was cut to remove the pipeline flex shield.The catheter total and usable length 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 issues; however, resistance was observed at the damaged locations.Based on the returned devices, the customer complaint was confirmed that the braid's distal end was not opened due to a damaged braid.The cause of the failure to open could not be determined.Possible causes of failure to open include vessel tortuosity and damaged braid.The customer reported that vessel tortuosity was normal, ruling out vessel tortuosity as a potential cause.The damaged braid may have contributed to the failure to open.The braid can become damaged due to resheathing more than two times, over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing the braid against resistance.However, the cause of the braid damage could not be determined.In addition, the pipeline flex shield was returned stuck inside the phenom catheter.The pipeline flex and catheter were damaged.From the damages seen on the catheter (accordioning), braid (fraying), pushwire (bending), and hypotube (stretching), it appears there was a high force used.These damages may have occurred when the customer attempted to advance/retrieve the pipeline flex shield through the catheter against resistance.However, the cause of resistance could not be determined.Possible resistance cause includes 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.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a pipeline shield device that failed to open at the distal end and then got stuck in the phenom 27 micro catheter during retrieval.The patient was undergoing an embolization procedure for flow diverter treatment of an ophthalmic artery segment unruptured saccular aneurysm.The aneurysm max diameter was 4mm and the neck diameter was also 4mm.Vessel tortuosity was normal.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared and catheter was flushed per the instructions for use (ifu).After the phenom 27 micro catheter was in place, the pipeline was delivered.The tip of the pipeline could not be opened.Despite repeated retrieval and redeployment, the pipeline tip still could not be opened so it was decided to retrieve it and remove from the patient's body.However, the pipeline got stuck in the proximal end of the micro catheter during retrieval and could not be removed.So both devices were removed and replaced to complete the procedure successfully.There was no harm or injury to the patient.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19568654
• Report Number: 2029214-2024-01100
• Device Sequence Number: 6112260
• Product Code: OUT
• UDI-Device Identifier: 00763000284701
• UDI-Public: 00763000284701
• 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): 08/29/2024

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: PED2-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: B684869
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 08/16/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/17/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sex: Unknown