MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNNK; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNK-CNV DCS COILS

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

Patient Problems Thromboembolism (2654); Nervous System Injury (2689)

Event Date 05/20/2005

Event Type  Injury  

Manufacturer Narrative

Procode: krd/hcg.Article attached to the mdr: valle, j.N., pierot, l., montalverne, f.Et al.(2005).Unruptured intracranial aneurysms treated by three-dimensional coil embolization: evaluation of the postoperative aneurysm occlusion volume.Neuroradiology (2005) 47: 438¿445 doi 10.1007/s00234-004-1320-1.Date of event, product code, and lot number could not be obtained from the author.Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable.Conclusion: the devices were not available for analysis.In addition, no lot numbers could be obtained; therefore, a dhr could not be performed for the devices.Thromboembolism and neurological deficits are known potential adverse event associated with the use of the coils as outlined in the instructions for use.Pharmacological and clinical factors including this patient¿s pre-procedure presentation with an aneurysm may have contributed to the event.Coil protrusion in the parent vessel and vessel occlusion are also known complications of coil embolization and can be associated to aneurysm characteristics including neck width.Coil non-detachment is a known procedural complication, and can be related to procedural/device handling factors.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 6 mdrs being submitted for this complaint, with associated report numbers of 2954740-2017-00185, 2954740-2017-00184, 2954740-2017-00183, 2954740-2017-00182, 2954740-2017-00186 and 2954740-2017-00181.

Event Description

In the literature article ¿unruptured intracranial aneurysms treated by three-dimensional coil embolization: evaluation of the postoperative aneurysm occlusion volume¿ by jean-noe¨ l valle´e, laurent pierot, francisco mont¿alverne, et al, published neuroradiology (2005) 47: 438¿445 doi 10.1007/s00234-004-1320-1, the authors evaluate the postoperative aneurysm occlusion volume and clinical results of treating unruptured intracranial aneurysms using three-dimensional (3d) coils (unknown catalog/lots of micrusphere, helipaq, or ultipaq).Complications included thromboembolism in three cases (with one experiencing neurological deficit and one experienced intermittent third nerve palsy), parent artery occlusion in one case, and coil protrusion in one case.Technical problems due to the coils were observed in three (0.7%) of the 413 coils used.These problems included non-detachment of coils in two (0.5%) cases and non-deployment in one (0.2%) case, with no clinical consequence.No patient, device or procedure specific information was provided in the article.From november 2000 to february 2003, 62 patients (43 women and 19 men) with 62 unruptured intracranial aneurysms were treated with micrus microcoils in five interventional neuroradiology centers.In all, 413 coils were used (114 spherical and 299 helical).Patients were 31 to 79 year of age.Five patients had presented with symptomatic intradural aneurysms, 11 patients had asymptomatic aneurysms ¿10 mm in diameter, eight patients had experienced a previous subarachnoid haemorrhage (sah) from other aneurysms, and seven patients had a positive family history for aneurysms or aneurysmal sah.Fifty-six (90%) aneurysms were located in the anterior circulation, and six (10%) in the posterior circulation all the aneurysms were first framed with one or more successive micrusphere coils of decreasing size and then filled with helical coils (helipaq, and extra-soft stretch-resistant ultipaq).Anatomical and clinical results were evaluated by univariate analysis.For neck sizes 4 mm, angiographic occlusion was complete in 31 (79%) and 16 (70%) aneurysms, respectively; the mean percentage of occlusion volume was 31.4% and 29.5%, respectively, and postoperative morbidity was 3% and 4%, respectively, with no significant differences between the two groups.There were no deaths.Technical complications were observed in five (8%) of the 62 procedures performed to treat 62 aneurysms.These complications were due to the procedure in three (8%) of the 39 procedures and two (9%) of the 23 procedures for treating aneurysms with a neck 4 mm, respectively.One (2%) patient had neurological deficit due to thromboembolism; his national institutes of health stroke scale (nihss) score was 7, and one (2%) patient had intermittent third nerve palsy for 48h.There were no deaths.

• Brand Name: UNNK
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6660584
• MDR Text Key: 78176718
• Report Number: 2954740-2017-00184
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CNV DCS COILS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability