MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKNOWN HELIPAQ CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNKHELIPAQ

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

Patient Problems Hemorrhage, Cerebral (1889); Hydrocephalus (3272)

Event Date 02/01/2008

Event Type  Death  

Manufacturer Narrative

Common device name: krd/hcg.The device catalog and lot number and the date of the procedure or death were not provided.No additional information could be obtained from the author.Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.The following article is attached to this mdr: white, j.B., cloft, h.J., kallmes, d.F., et al.(2008).But did you use hydrocoil? perianeurysmal edema and hydrocephalus with bare platinum coils.Am j neuroradiol 29:299 ¿300, feb 2008.Conclusion: the devices were not available for analysis.In addition, the lot numbers were not provided; therefore, a dhr review could not be performed.Allergic reactions to metals are well known potential reactions associated with all implantable metal medical devices.There were multiple brands of coils implanted; therefore, is it not possible to determine if the event was related to the codman coils implanted.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 2 mdr reports being submitted for this complaint, with associated report numbers of 2954740-2017-00121 and 1226348-2017-00069.

Event Description

In the literature article ¿but did you use hydrocoil? perianeurysmal edema and hydrocephalus with bare platinum coils¿ by j.B.White; h.J.Cloft; d.F.Kallmes, published am j neuroradiol 29:299 ¿300, feb 2008, it was reported that a patient who had received implantation of 17 coils (including an unspecified number of orbit trufill coils and helipaq coils), experienced visual scintillations in the right eye consistent with his migraine auras within 24 hours of the procedure, and one week later developed marked brain stem edema with symptoms of headache, disequilibrium, abducens palsy and internuclear ophthalmoplegia.During the course of cortical steroid treatment, he developed hydrocephalus and expired on post-coiling day 18.The (b)(6) male patient had presented with an incidentally discovered right vertebral artery aneurysm that measured 17 x 17 x 15 mm as detected on ct angiography.The pretreatment ct scan revealed no evidence for pre-existing cerebral or brain stem edema.He was pre-medicated with aspirin and clopidogrel.Under general anesthesia, the patient underwent coiling of the aneurysm with a total of 17 bare platinum coils from 2 different manufacturers (orbit trufill, (b)(4); helipaq, micrus endovascular, (b)(4); and microplex, microvention, (b)(4)).The packing attenuation following coiling was calculated at 13%.During the ensuing 24 hours, the patient developed visual scintillations in the right eye, which were consistent with his well-documented migraine auras.A follow-up angiogram 1 day following the coil procedure showed complete aneurysm occlusion and no evidence for parent artery compromise or distal emboli.On the third hospital day, the patient was dismissed home and was maintained on aspirin and clopidogrel.Approximately 1 week after the coiling, the patient presented to his local hospital with symptoms of headache, dysequilibrium, abducens palsy, and internuclear ophthalmoplegia.An mr imaging showed the coiled aneurysm in the setting of marked brain stem edema.At that time, angiographic findings were unchanged as compared with the patient¿s angiogram obtained at the time of his coiling.Corticosteroids were initiated, but during the course of the following 5 days, the patient developed hydrocephalus, necessitating placement of an external ventricular drain, as well as a posterior fossa hemorrhage.His neurologic status continued to decline with the family withdrawing support on post-coiling day 18.The article also reported another case of brain stem edema post-implantation of microplex, microvention coils.No device specific information was provided in the article (i.E.Catalogue/lot number), and no additional information could be obtained from the author.

• Brand Name: UNKNOWN HELIPAQ CERECYTE MICROCOIL
• 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: 6622507
• MDR Text Key: 77000165
• Report Number: 2954740-2017-00121
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKHELIPAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/08/2017
• 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
• Treatment: MICROPLEX, MICROVENTION
• Patient Outcome(s): Death
• Patient Age: 73 YR