MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNK COIL-HYDRAULIC; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNK COIL-HYDRAULIC

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

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Transient Ischemic Attack (2109); Visual Disturbances (2140); Loss of consciousness (2418); Cognitive Changes (2551); Decreased Sensitivity (2683); Embolism/Embolus (4438)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Zhang berlin, zhang zhenyu, zou mingang, zeng hailan, huang jinqing, zhou xiaoping, yang ruijin, jiang qiuhua.Application of neurophysiological monitoring in endovascular treatment of intracranial aneurysms.China modern medicine, december 2020, vol.27, no.36 the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.Since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

This complaint is from a literature source and the following citation was reviewed: zhang berlin, zhang zhenyu, zou mingang, zeng hailan, huang jinqing, zhou xiaoping, yang ruijin, jiang qiuhua.Application of neurophysiological monitoring in endovascular treatment of intracranial aneurysms.China modern medicine, december 2020, vol.27, no.36 objective and methods: to investigate the application of neurophysiological monitoring in endovascular treatment of intracranial aneurysms.A total of 112 patients with intracranial aneurysms treated with endovascular therapy in ganzhou hospital affiliated to nanchang university from october 2015 to june 2018 were selected as the study subjects and divided into two groups according to whether neurophysiological monitoring was used during the operation, including 42 patients in the monitoring group and 70 patients in the unmonitored group.Somatosensory evoked potentials (sep), motor evoked potentials (mep), brainstem auditory evoked potentials (baep), and scalp electroencephalography (eeg) were monitored according to aneurysm site, and modified rankin scale (mrs) scores were used to assess clinical outcomes during patient follow-up.The new neurological dysfunction within 24 h after operation and the prognosis at 6 months after operation were compared between the two groups.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: mechanical detachable microcoils, enterprise stent other cerenovus devices that were also used in this study: n/a.Non-cerenovus devices that were also used in this study: non-cerenovus microcoils, solitaire stent (ev3).The article does not specify which manufacturer device is associated with the adverse events.Therefore, exact quantities of impacted products cannot be accurately determined and exact number of patient symptoms cannot be accurately determined as a patient may experience more than one symptom.Adverse event(s) and provided interventions: 2 cases in monitoring group & 15 cases in non monitoring group with new nerve dysfunction within 24 h after operation including decreased muscle strength, decreased level of consciousness and hemiplegia(6), limb sensory disturbance, aphasia (1), visual field defect (1).Aneurysm rupture - treated by intervention intraoperatively (no details provided).Cerebral ischemia - (no details provided).Vascular embolism - (no details provided).

• Brand Name: UNK COIL-HYDRAULIC
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12666550
• MDR Text Key: 277461668
• Report Number: 3008114965-2021-00530
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123560
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK COIL-HYDRAULIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MICROCOILS, SOLITAIRE STENT (EV3)
• Patient Outcome(s): Life Threatening; Required Intervention