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

Model Number	PED-350-16
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that there was resistance and the pipeline failed to open.The patient was undergoing surgery for embolization treatment of an amorphous, unruptured aneurysm-cavernous in the sinus segment with a max diameter of 12mm and a 8mm neck diameter.The landing zone was 3.14mm at the distal end and 3.35mm at the proximal end.The access vessel was 8f with a diameter of 20mm.It was noted the patient's vessel tortuosity was moderate.It was reported that ped implantation was required for aneurysm embolization.The patient¿s path was moderately tortuous, and a phenom27 catheter was used to deliver a 3.5*16 ped stent.After the microcatheter was in place, the ped was delivered.The distal end could not be pushed (failure to open), and the resistance was large in the distal section, and it could not pass through repeated attempts.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.It was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.Re-replacement was given without causing personal injury as it was removed with the microcatheter.The pipeline was not used for an indication that is not approved (off-label).The pipeline and any accessory devices prepared as ind icated in the ifu.The catheter flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.  ancillary devices include a johnson <(>&<)> johnson sheath, johnson <(>&<)> johnson guide catheter, phenom microcatheter, stryker guidewire, and ev32-6 coils.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12657243
• Report Number: 2029214-2021-01297
• Device Sequence Number: 4233367
• Product Code: OUT
• UDI-Device Identifier: 00847536015333
• UDI-Public: 00847536015333
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 11/18/2023
• Device Model Number: PED-350-16
• Device Catalogue Number: PED-350-16
• Device Lot Number: B120371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR