MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NV MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MICROCATH

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

Patient Problem Paralysis (1997)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

Reported patient age is representative of the average patient age in the study, not necessarily of the patient who experienced the reported adverse event.The reported patient sex is representative of the majority of patient included in the study, not necessarily of the patient who experienced the reported adverse event.If information is provided in the future, a supplemental report will be issued.

Event Description

Xu, b., wang, z., bai, w., & li, t.(2019).Treatment of cavernous sinus dural arteriovenous fistula using different surgical approaches: analysis of 32 consecutive cases. journal of interventional medicine, 2(3), 118¿122.Https://doi.Org/10.1016/j.Jimed.2019.09.011 medtronic review of the literature article found described the review of 32 cases from a single facility in which cavernous sinus dural arteriovenous fistula (csdavf) was treated between may 2009 and may 2014.There were 25 female patient and 7 male patients in the study population.The average age was 50.8 years.The manifestations on digital subtraction angiography (dsa) were classified according to barrow types, with 15 cases of type c simple external carotid artery dural shunts, and 17 cases of dural shunts from the meningeal branches of the external and internal carotid arteries.All patients had ophthalmic venous drainage, though type/location varied.All patients underwent routine diagnostic dsa prior to surgery.Type of embolization procedure and approach was determined based on angioarchitectural features, these being: 1) blood supply, 2) position of the davf (front, simple blood-supplying artery; back, vein approach), and 3) draining vein.8 patients included in the study underwent treatment through iaa (inferior arterial approach).In these procedures the right femoral artery was punctured, a 5/6f artery sheath was implanted, and the proper blood-supplying artery was chosen based on the diameter, length, tortuosity, and type of collateral branch determined using super-selective angiography.An echelon-10 or marathon microcatheter was used to super-selectively approach the cavernous sinus fistula with the aid of a micro guidewire, and the angioarchitecture was revealed through super-selective angiography, thus avoiding dangerous anastomoses.Spring coil embolization was performed on the fistula to slow down the blood flow, when necessary.Subsequently, onyx les was slowly injected using the roadmap-bolus-diffusion-pause-roadmap-bolus method.Angiography was repetitively conducted during the onyx injection to observe the status of the cavernous sinus embolization.The surgery was terminated once the fistula disappeared.Among eight iaa cases, two cases were failures and were successfully embolized through ipsa.Six cases were treated with onyx embolization alone (including one case that failed with the venous approach and was switched to iaa), and one was treated with spring coils combined with onyx embolization.One patient treated with the iaa approach method, experienced prosopoplegia considered to be related to procedure related which impr oved.No additional medical or surgical treatment was reported.

• Brand Name: NV MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11665881
• MDR Text Key: 247662255
• Report Number: 2029214-2021-00425
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MICROCATH
• Device Catalogue Number: UNK-NV-MICROCATH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• 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): Disability
• Patient Age: 50 YR