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

Model Number	PED-475-25
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is being reported at this time based on analysis results.Product analysis: a pipeline flex embolization device, a phenom-27 catheter and a navien guide catheter were returned for analysis within a shipping box; within a sealed biohazard bag and within an opened pipeline flex embolization device inner pouch.The pipeline flex device was returned inverted within the phenom-27 hub.The pipeline device was extending ~70.3cm from hub.No bends or kinks were found with the pipeline flex pushwire.The hypotube was found to be stretched with ptfe pulled back.The proximal bumper, pad, and pad restraint were found to be intact.The dps sleeves and tip coil were found to be missing.The braid was found to be missing and not returned.Based on the analysis findings, the customer¿s report of ¿resistance in catheter hub¿ and ¿catheter resistance at hub¿ were unable to be confirmed and the root cause could not be determined.Possible causes of ¿resistance in hub¿ are tortuosity of patient anatomy, introducer sheath did not sit securely inside hub, user does not maintain a continuous flush, or user pulls back on/torques wire during insertion.The customer reported use of a continuous flush and introducer sheath sat securely within hub; therefore, these could be ruled out as potential causes.There was no device malfunction or non-conformance to specifications identified that led to the resistance during delivery.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the pipeline was deployed during the operation, it was found that it stuck at the catheter hub and could not be pushed out.The catheter was flushed continuously with heparinized saline.The tip of the sheath was seated securely in the hub.There was no catheter or pushwire damage.The patient was undergoing surgery to treat unruptured, amorphous aneurysms of the right middle cerebral and internal carotid segments of the ophthalmic artery with a max diameter of 10mm and a neck diameter of 5mm.The distal landing zone was 2.5mm, and the proximal landing zone was 4.6.The access vessel was the femoral artery, and its diameter was 3mm.It was noted the vessel tortuosity was moderate.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.

• 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: 12652815
• Report Number: 2029214-2021-01296
• Device Sequence Number: 4233366
• Product Code: OUT
• UDI-Device Identifier: 00847536016774
• UDI-Public: 00847536016774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018 S033
• 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): 10/18/2021

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: 12/03/2023
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: B126643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR