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

Model Number UNKNOWN

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

Patient Problems Intracranial Hemorrhage (1891); Muscle Weakness (1967)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Justin schwarz, joseph a.Carnevale, jacob l.Goldberg, alexander d.Ramos, thomas w.Link, and jared knopman.Perioperative prophylactic middle meningeal artery embolization for chronic subdural hematoma: a series of 44 cases.Journal of neurosurgery (2021).Doi: 10.3171/2020.10.Jns202856.Objective chronic subdural hematoma (csdh) is a common and challenging pathology to treat due to both the historically high recurrence rate following surgical evacuation and the medical comorbidities inherent in the aging patient population that it primarily affects.Middle meningeal artery (mma) embolization has shown promise in the treatment of csdhs, most convincingly to avoid surgical evacuation in relatively asymptomatic patients.Symptomatic patients requiring surgical evacuation may also benefit from perioperative mma embolization to prevent csdh recurrence.The goal of this study was to determine the utility of perioperative mma embolization for symptomatic csdh requiring surgical evacuation and to assess if there is a decrease in the csdh recurrence rate compared to historical recurrence rates following surgical evacuation alone.Methods symptomatic csdhs were evacuated using a subdural evacuating port system (seps) with 5-mm twist-drill craniostomy in an intensive care unit or by performing a craniotomy in the operating room, using either a small (silver dollar, <(><<)> 4 cm) or large (= 4 cm) craniotomy.Mma embolization was performed perioperatively using angiography, selective catheterization of the mma, and infusion of polyvinyl particles.Outcomes were assessed clinically and radiographically with interval head ct imaging.Results there were 44 symptomatic csdhs in 41 patients, with 3 patients presenting with bilateral symptomatic csdh.All csdhs were evacuated using an seps (n = 18), a silver-dollar craniotomy (n = 16), or a large craniotomy (n = 10).Prophylactic mma embolization was performed successfully in all csdhs soon after surgical evacuation.There were no deaths and no procedural complications.There was an overall reduction of greater than 50% or resolution of csdh in 40/44 (90.9%) cases, regardless of the evacuation procedure used.Of the 44 prophylactic cases, there were 2 (4.5%) cases of csdh recurrence that required repeat surgical evacuation at the 1-year follow-up.These 2 csdhs were initially evacuated using an seps and subsequently required a craniotomy, thereby representing an overall 4.5% recurrence rate of treated csdh requiring repeat evacuation.Most notably, of the 26 patients who underwent surgical evacuation with a craniotomy followed by mma embolization, none had csdh recurrence requiring repeat intervention.Conclusions perioperative prophylactic mma embolization in the setting of surgical evacuation, via either craniotomy or seps, may help to lower the recurrence rate of csdh.Reported events - recurrence of the subdural collection thereby requiring repeat surgical evacuation occurred in 4.5% (2/44) of cases.Both repeat s urgical evacuations were primarily in the seps group.These 2 patients re-presented to the hospital on post-mma embolization days 23 and 33 with progressionof initially presenting neurological symptoms (extremity weakness) and radiographic findings of csdh reaccumulation and progression.Comparing radiographic findings for these 2 patients on the post-mma embolization ct, the largest diameter/midline shift progressed from 11/2 mm to 24/4 mm in the first patient and from 14/6 mm to 22/7 mm in the second patient on the representative ct.

• 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: 12558212
• MDR Text Key: 274928618
• Report Number: 2021898-2021-00170
• 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
• 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

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2021
• 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): Hospitalization; Required Intervention