MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNKDELTAPLUSH

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

Patient Problem Brain Injury (2219)

Event Date 03/31/2015

Event Type  Injury  

Manufacturer Narrative

This is initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00170.Additional procode: krd.Udi unavailable; lot unknown.Concomitant medical products: microplex-10 complex 3/7 coil (terumo, (b)(4)), hyperform 4 × 7 balloon (micro therapeutics inc, (b)(4)).White matter lesions, described as neurologic deficits, are known potential adverse event associated with the use of the codman embolic coil devices.Although there is not product specific information available, all products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that the specific patient immunologic response may have contributed to the report of white matter lesions.There is no evidence of manufacturing related issues.No further actions are required at this time.

Event Description

In the literature article ¿a patient develops transient unique cerebral and cerebellar lesions after unruptured aneurysm coiling¿ by kentaro deguchi, yuko kawahara, shoko deguchi, nobutoshi morimoto, tomoko kurata, yoshio ikeda, tomotsugu ichikawa, koji tokunaga, nobuyuki kawai, kenji sugiu and koji abe, published bmc neurology (2015) 15:49, doi 10.1186/s12883-015-0303-7, it was reported that after implantation of unknown deltaplush and unknown competitor¿s coils, the patient developed unusual cerebral lesions.Per the article: ¿a (b)(6) woman presented an incidental 3.7 × 3.3-mm unruptured cerebral aneurysm (can) in her basilar artery, which was successfully coiled with balloon assistance.A follow-up brain mri at 1 and 2 months showed a gradual increase in several white matter hyperintense lesions in the left cerebellar, bilateral occipitotemporal and left parietooccipital lobe during fluid-attenuated inversion recovery (flair).These were the only lesions associated with perfused can.However, the patient did not show any additional symptoms such as visual disturbance throughout the entire course.The 11c-methionine-pet (met-pet) showed an obvious increase in methionine uptake in the lesion corresponding to enhanced areas with gadolinium-enhanced mri.Mrs showed a decrease in the n-acetylaspartate/ creatine (naa/cr) ratio and a slight elevation of the choline/creatine (cho/cr) ratio and a lactate peak in the lesion.A follow-up mri at 6 and 12 months showed a gradual decrease in the initial hyperintense lesions in flair without any treatment.¿ at the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: DELTAPLUSH - 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: 6650116
• MDR Text Key: 77862457
• Report Number: 2954740-2017-00170
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKDELTAPLUSH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• 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
• Patient Age: 33 YR