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

Model Number	PED-500-35
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex embolization device and phenom 27 catheter were returned for analysis within a shipping box; within a primary plastic bio-pouch and within a secondary plastic bio-pouch.The phenom 27 catheter was returned separated (cut) into 16 segments.In addition, only the pipeline flex distal segment (ptfe sleeves and tip coil) was returned.It appears the pipeline flex distal core wire separated at the ptfe sleeves.The ptfe sleeves and tip coil were found to be in good condition.No damage was found with the phenom 27 catheter hub.The useable lengths of the returned phenom 27 catheter segments (16) were measured to be ~2.0cm, 1.2cm, 7.2cm, 6.3cm, 1.5cm, 1.5cm, 1.1cm, 0.9cm, 0.9cm, 0.5cm, 0.9cm, 1.7cm, 1.8cm, 2.2cm, 2.4cm, and 67.5cm.It could not be determined if the entire phenom 27 catheter was returned as the model number was not reported.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ could not be confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.However, the cause for the resistance could not be determined.Regarding the phenom 27 catheter separation (cut) and pipeline flex distal core wire separation the causes could not be determined as this was not reported by the customer.There is insufficient information to determine cause.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that while advancing the pipeline into the phenom 027 microcatheter, the physician felt resistance in the proximal segment.The slack was released in the system, but was unsuccessful at resolving the issue.A continuous flush had been used.The catheter and pipeline were removed, and the pipeline never advance further than the tip of the catheter.There was no damage observed to the pipeline pushwire or the catheter.After removing the system, a pipeline of the same size was successfully implanted with a new phenom microcatheter.It was indicated that all devices were prepared as per the instructions for use (ifu), and there was no patient involvement with the event.

• 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: 11206225
• Report Number: 2029214-2021-00077
• Device Sequence Number: 3382627
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 09/01/2023
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: B079709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1