MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	104-4770
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
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 information regarding a pipeline stent device that failed to open.When retrieving failed pipeline, it became stuck at the distal end of the phenom catheter.A hyperform balloon ruptured during the same procedure after the pipeline deployment failure.The patient was being treated for an unruptured 28mm fusiform aneurysm of the internal carotid artery.Vessel tortuosity was severe.It was reported that a navien intracranial support catheter was navigated to the aneurysm site.The phenom catheter and guide wire were then navigated to the distal neck of the aneurysm.The pipeline was delivered to the tip of the phenom microcatheter.However pipeline deployment failed.When trying to retrieve the pipeline, significant resistance was felt with the pipeline at the distal end of the phenom microcatheter so the devices were removed together.After pipeline deployment failure, use of a hyperform balloon was attempted but the balloon ruptured.The balloon was replaced with a non-medtronic balloon and afterward 4 pipeline stents were successfully placed to complete the procedure.All devices were prepared and catheters flushed per the instructions for use (ifu).There was no harm or injury to the patient.Post-op angio showed eclipse sign.

• Brand Name: HYPERFORM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10267795
• Report Number: 2029214-2020-00687
• Device Sequence Number: 11338166
• Product Code: MJN
• UDI-Device Identifier: 00836462004207
• UDI-Public: 00836462004207
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: 07/31/2021
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: A874804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1