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

Model Number	PED-500-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please see mfr report number 2029214-2020-01251 for additional device involved associated with the event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the distal end of the pipeline had trouble opening, and the proximal end of the 5mm x 18mm did not open at all even when removed, only when the device was forced off the wire that it opened.The 5mm x 20mm was still in the catheter.The pipelines were not positioned in a bend.More than 50% had been deployed when it failed to open.The pipelines were reheated less than or equal to 2 times.The pipelines were reheated and removed with the microcatheter from the patient.It was noted the pipelines were used for a cc fistula which was not an approved indication.The patient was undergoing surgery to treat an cc fistula at the left internal carotid artery with a distal landing zone of 4.7mm and a proximal landing of 5.2mm.It was noted the vessel tortuosity was normal.There were no patient symptoms associated with the event.The angiographic result post procedure indicated that the 5mm x 16mm pipeline worked.The patient's medical history included a previous trauma (car accident).

• 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: 10971713
• Report Number: 2029214-2020-01252
• Device Sequence Number: 4214517
• Product Code: OUT
• UDI-Device Identifier: 00847536019690
• UDI-Public: 00847536019690
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/08/2020

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: 06/12/2023
• Device Model Number: PED-500-18
• Device Catalogue Number: PED-500-18
• Device Lot Number: B039402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR