MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UKNOWN SEPS KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 11-0401-CAL

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

Patient Problem Insufficient Information (4580)

Event Date 04/24/2021

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Austin carpenter, mitchell rock, ehsan dowlati, charles miller, jeffrey c.Mai, ai-hsi liu, rocco a.Armonda, daniel r.Felbaum.Middle meningeal artery embolization with subdural evacuating port system for primary management of chronic subdural hematomas.Neurosurgical review (2021).Doi: 10.1007/s10143-021-01553-x abstract optimal treatment for chronic subdural hematomas remains controversial and perioperative risks and comorbidities may affect management strategies.Minimally invasive procedures are emerging as alternatives to the standard operative treatments.We evaluate our experience with middle meningeal artery (mma) embolization combined with subdural evacuating port system (seps) placement as a first-line treatment for patients with csdh.A single institution retrospective review was performed of all patients undergoing intervention.Patients were stratified by treatment with mma embolization and seps placement, mma embolization and surgery, seps placement only, and surgery only for csdh from 2017 to 2020, and cohorts were compared against each other.Patients treated with mma/seps were more likely to be older, be on anticoagulation, have significant comorbidities, have shorter length of stay, and less likely to have symptomatic recurrence compared to seps only cohort.Thus, mma/seps appears to be a safe and equally effective minimally invasive treatment for csdh patients with significant comorbidities who are poor surgical candidates.Reported events.- 30-day mortality for the mma embolization + seps included 1 patient.- 30-day mortality for seps only included 2 patients.

• Brand Name: UKNOWN SEPS KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12558468
• MDR Text Key: 274199568
• Report Number: 2021898-2021-00172
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11-0401-CAL
• Device Catalogue Number: 11-0401-CAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/30/2021
• 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): Death