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

Model Number PED-450-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Neurological Deficit/Dysfunction (1982)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was successfully implanted on the patient.The events reported occurred six weeks post the embolization procedure and its exact cause remains unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the device occurred during the treatment procedure.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure and patient conditional related event.Linked events: 2029214-2018-00300, 2029214-2018-00301, 2029214-2018-00302.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report through literature review of " transvenous aneurysm sac and rupture point coil embolization of direct carotid cavernous fistula after pipeline embolization".The postoperative course was uneventful and uneventful embolization procedure, the patient was discharged at the neurological baseline 10 days after the procedure with the same dapt regimen.Six weeks after the ped embolization, the patient suffered a sudden onset of a severe headache following pulsatile tinnitus and progressive worsening of the right visual acuity without any head injuries.Dsa images showed the development of a right direct carotid cavernous fistula (dccf) that drained into the right superior ophthalmic vein, the pterygoid venous plexus, the inferior petrosal sinus, the superior petrosal sinus, and via the intercavernous sinus into the contralateral cavernous sinus (cs).It was determined from the balloon occlusion test (bot) that the patient could not tolerate a permanent carotid occlusion, a transvenous coil embolization was indicated as a treatment option to preserve the ica flow.Under general anesthesia and systemic heparinization, a 4f diagnostic catheter was inserted into the right ica via the left femoral artery sheath to provide a roadmap guidance and control angiography.After the 6f sheath was introduced in the right common femoral vein, the tip of the 4f inner catheter coaxially assembled with the 6f guiding catheter was cannulated into the origin of the right inferior petrosal sinus via the internal jugular vein.A excelsior sl-10 (stryker) was advanced into the cs and further inserted into the aneurysm sac via the rupture point with the assistance of the microguidewire.After the aneurysm sac was embolized with some coils, the microcatheter was pulled back into the cs, and a few coils were put into the part of the cs adjacent to the rupture point for complete occlusion.Post-treatment dsa images showed complete resolution of the dccf with aneurysm sac occlusion.Pulsatile tinnitus disappeared and the right visual acuity gradually improved.The patient was discharged with the same dapt regimen.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7444942
• MDR Text Key: 106007060
• Report Number: 2029214-2018-00300
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-450-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR