MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNK COIL-HYDRAULIC

Catalog Number UNK COIL-HYDRAULIC

Device Problem Migration (4003)

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Literature article "short- and intermediate-term angiographic and clinical outcomes of patients with various grades of coil protrusions following embolization of intracranial aneurysms" reviewed.Abdihalim m, kim sh, maud a, suri mf, tariq n, qureshi ai.Short- and intermediate-term angiographic and clinical outcomes of patients with various grades of coil protrusions following embolization of intracranial aneurysms.Ajnr am j neuroradiol.2011 sep;32(8):1392-8.Doi: 10.3174/ajnr.A2572.Epub 2011 sep 1.Pmid: 21885722; pmcid: pmc7964362.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

Literature article "short- and intermediate-term angiographic and clinical outcomes of patients with various grades of coil protrusions following embolization of intracranial aneurysms" reviewed.Abdihalim m, kim sh, maud a, suri mf, tariq n, qureshi ai.Short- and intermediate-term angiographic and clinical outcomes of patients with various grades of coil protrusions following embolization of intracranial aneurysms.Ajnr am j neuroradiol.2011 sep;32(8):1392-8.Doi: 10.3174/ajnr.A2572.Epub 2011 sep 1.Pmid: 21885722; pmcid: pmc7964362."objective and methods: an infrequent occurrence during endovascular treatment is protrusion of detachable coils into the parent lumen with a subsequent thrombosis within in the parent vessel or embolic events.We report the short- and intermediate-term angiographic and clinical outcomes of patients who experience coil or loop protrusions and are managed with medical or additional endovascular treatments.The coil protrusions were identified by retrospective review of 256 consecutive patients treated at 3 centers with endovascular embolizations for intracranial aneurysms and subsequently categorized as grade i when a single loop or coil protruded into the parent vessel lumen less than half the parent artery diameter; grades ii and iii were assigned when a single coil or loop protruded more than half the parent artery diameter, respectively.There were 19 patients with grade i (n = 9), grade ii (n = 4), or grade iii (n = 6) coil protrusions.Patients with active hemodynamic compromise (n = 6) had intracranial stents placed in addition to aspirin (indefinitely) and clopidogrel (range, 1¿12 months; mean, 4.5 months) treatment.The remaining patients were placed on aspirin indefinitely.Complete aneurysm obliteration was achieved in all patients except in 3 in whom near-complete obliteration was achieved.Two patients had intraprocedural aneurysm ruptures, both of whom survived hospitalization.There were 4 deaths (4 ¿21 days), all due to major strokes in different vascular distributions related to vasospasm (unrelated to the coil protrusion).Management of coil protrusions with antiplatelet therapy and placement of stents (in selected patients) appears efficacious in preventing vessel thrombosis.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: envoy guide catheter (cordis, miami lakes, florida).Trufill dcs orbit (cordis).Enterprise stent (cordis).Non-cerenovus devices that were also used in this study: neuroform stents (boston scientific).Gdcs (boston scientific).Hydrocoil (microvention terumo, aliso viejo, california).Microcoil (micrus endovascular, san jose, california).Adverse event(s) and provided interventions: there were 10 patients with major coil/loop protrusions and 9 with minor coil/loop protrusions.All the events were either single coil or loop protrusions.Of the 10 patients - hemodynamic alterations.Attempted multiple times to readjust coils.Intraprocedural aneurysm ruptures during coil/loop protrusions.Managed with anti-coags.".

• Brand Name: UNK COIL-HYDRAULIC
• Type of Device: COIL-HYDRAULIC
• 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 ; 9497898687
• MDR Report Key: 12566341
• MDR Text Key: 278092106
• Report Number: 3008114965-2021-00489
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2021
• 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: 09/06/2021
• 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
• Patient Outcome(s): Life Threatening