MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKNOWN DCS COIL; CNV DCS COILS

Catalog Number UNKDCSCOIL

Device Problem No Apparent Adverse Event (3189)

Patient Problem Weakness (2145)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

This is an initial/final report.Unknown part number, udi unavailable.In the literature article ¿neurological changes with abnormal brain reactivity following coiling of cerebral aneurysm.Possible reactivity to endovascular devices and material?¿ by sanjeet s.Grewal, md, eric m.López del valle, md, vivek gupta, md, navarro ramon, md, w.David freeman, md and rabih g.Tawk, md, published jvin, vol.8, no.3, pp.28¿36.Published july, 2015.It was reported that a female patient presented with headaches and underwent coiling of an unruptured posterior communicating artery aneurysm.A few days later, she developed left-sided weakness.Mri revealed enhancing white matter lesions in the ipsilateral hemisphere.The patient underwent extensive work-up and was treated with a prolonged course of immunosuppression.This report describes the case of abnormal brain reactions with significant neurological side effects following coiling of an intracranial aneurysm.The patient was treated with immunomodulation for a prolonged period of time and became dependent on this treatment to maintain the stability of her disease.Based on our interpretation of previous cases [8] and our case, the reaction is likely related to detached material from endovascular devices, as the enhancement was confined to the same vascular tree of the treated aneurysm.Although the insulting agent remains unknown, the reaction is not likely to be related to the pgla coils, as the patient had no reaction to implanted coil materials and pgla while off immunosuppression.At the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.Neither the catalogue number nor the lot number was available thus neither dhr nor fal could be completed.Neurologic deficit/consequences are known potential adverse events associated with the use of the codman embolic coils.The ifu for the codman embolic coils specifically states that neurologic deficits may occur.All products undergo a 100% inspection prior to release for marketing.Review of the information suggests that patient reactivity factors may have contributed to the reported event.

Event Description

In the literature article 쎅urological changes with abnormal brain reactivity following coiling of cerebral aneurysm.Possible reactivity to endovascular devices and material?by sanjeet s.Grewal, md, eric m.LӐez del valle, md, vivek gupta, md, navarro ramon, md, w.David freeman, md and rabih g.Tawk, md, published jvin, vol.8, no.3, pp.28-36.Published july, 2015.It was reported that a female patient presented with headaches and underwent coiling of an unruptured posterior communicating artery aneurysm.A few days later, she developed left-sided weakness.Mri revealed enhancing white matter lesions in the ipsilateral hemisphere.The patient underwent extensive work-up and was treated with a prolonged course of immunosuppression.This report describes the case of abnormal brain reactions with significant neurological side effects following coiling of an intracranial aneurysm.The patient was treated with immunomodulation for a prolonged period of time and became dependant on this treatment to maintain the stability of her disease.Based on our interpretation of previous cases [8] and our case, the reaction is likely related to detached material from endovascular devices, as the enhancement was confined to the same vascular tree of the treated aneurysm.Although the insulting agent remains unknown, the reaction is not likely to be related to the pgla coils, as the patient had no reaction to implanted coil materials and pgla while off immunosuppression.At the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: UNKNOWN DCS COIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 325 paramount dr; raynham, MA 02767 ; 5089777396
• MDR Report Key: 5383566
• MDR Text Key: 36545326
• Report Number: 1226348-2016-00010
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K053160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKDCSCOIL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR