MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNKNOWN CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number UNKCERECYTE

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

Patient Problems Edema (1820); Paresis (1998); Dysphasia (2195)

Event Date 07/01/2013

Event Type  Injury  

Event Description

Review of a literature article jawid, madjidyar; ulrike, brandt; andreas, binder; olav, jansen, neuroradiology (2014) 56: 1129-1132, ¿late occurrence of a symptomatic perianeurysmal edema and wall enhancement after coil embolization¿ revealed that approximately eight (8) years post coiling the patient presented with transient right sided hemiparesis, aphasia and dysarthria.In (b)(6) 2005, a (b)(6) year-old female patient, underwent successful coil embolization of three (3) incidental aneurysms.The aneurysms were located in the m2-segment of the right middle cerebral artery (mca; 4x3x3 mm; neck width, 1.6 mm), in the distal left internal carotid artery (ica; 6.8x3.4x3.3 mm; neck width, 2.8mm), and in the a-1 segment of the left anterior cerebral artery (aca; 5.1x4.6x4.6 mm; neck width, 1.8mm).Two types of coils were used; bare platinum coils and bio-active coils.The bare platinum and one type of bio-active coils were from competitor companies and the second type of bio-active coils used was micrus cerecyte.The procedure was successfully completed without any report of issues, and follow up imaging was done without report of issues at four (4) days, one (1) year and two (2) years post index procedure.Approximately eight (8) years post index, the patient presented with transient right sided hemiparesis, aphasia and dysarthria.During hospitalization further episodes were witnessed.Mri revealed perianeurysmal brain edema and wall enhancement of the aneurysm in the left ica.The other two treated sites had no pathologic findings.All additional lab findings supported the diagnosis of late aseptic inflammatory reaction secondary to foreign body reaction which was treated with a course of corticosteroids.With the treatment the hemiparesis and dysarthria did not reappear; however, transient headache did persist.Follow up mri after one week and three weeks showed progressive almost complete resolution of the brain edema and wall enhancement.Up to 2 years post steroid treatment there was no reoccurrence of the edema symptoms.

Manufacturer Narrative

Concomitant products: gdc ultrasoft (boston scientific, lot unknown)/ matrix 2 coil (boston scientific, lot unknown)/ the product is implanted and will not be returned.Conclusions on the event are being formulated and are forthcoming.

Manufacturer Narrative

The devices were not available for analysis.No sterile lot number was reported thus no dhr could be conducted.Although aseptic inflammation is not specifically listed in the product labeling as a potential adverse events associated with use of the devices, the symptoms reported are neurologic changes.Per the microcoil ifu possible adverse events include, but are not limited to, the following: hematoma at site of entry, vessel perforation, infection, emboli, hemorrhage, ischemia or vasospasm, neurological deficits including stroke, and possibly death.All products are 100% inspected prior to leaving the manufacturing facility and there is no evidence of a manufacturing related issue.Review of the limited information suggests that patient physiologic factors may have contributed to the reported events.

• Brand Name: UNKNOWN CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4461522
• MDR Text Key: 15316091
• Report Number: 2954740-2015-00038
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K022420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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: UNKCERECYTE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR