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

Model Number PED-425-25

Device Problems Retraction Problem (1536); Material Deformation (2976); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id fg15150-0615-1s (lot: 227034084); 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.

Event Description

Medtronic received a report that the pipeline failed to open and encountered resistance during retrieval in the phenom catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right c5 segment with a max diameter of 4.9 mm and a 5.1 mm neck diameter.Landing zone: distal: 4.0 mm and proximal: 4.4 mm.The accessed vessel was the femoral artery with a diameter of 9 mm.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet treatment was administered.The pru level was iia.The angiographic result post procedure showed smooth blood flow.It was reported that the pipeline stent couldn't be opened at the anterior ascending and anterior curvature of the cavernous sinus s egment.After recycling, it still appeared flat.During the second retrieval, the microcatheter had resistance and retrieval was difficult.The surgeon exerted great force during retrieval.The stent was suspected to be damaged and the stent could not be retracted into the microcatheter.After several attempts, the stent and microcatheter were removed.The stent was damaged when observed in vitro, but the microcatheter and stent could be detached when outside the body.A shorter stent was chosen, and the surgery was successfully completed.The pipeline was not used as an indication that is off-label.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.

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 Description

Additional information received reported that the middle section of the pipeline didn¿t open.The pipeline had been placed in a vessel bend when it failed to open.Resheathing was attempted to open the pipeline.The resistance was found in the middle and proximal sections.

• Brand Name: PIPELINE FLEX
• Type of Device: 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18932241
• MDR Text Key: 338312737
• Report Number: 2029214-2024-00470
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-425-25
• Device Catalogue Number: PED-425-25
• Device Lot Number: B470697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2024
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 58 KG