MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC UNKNOWN HELIPAQ CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number UNKHELIPAQ

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

Patient Problem Nerve Damage (1979)

Event Date 08/03/2010

Event Type  Injury  

Event Description

As reported via the (b)(4) study, (b)(6) a patient experienced left cranial nerve palsy (3rd nerve palsy) after 8 cerecyte coils (4 presidio, 3 helipaq, and 1 cashmere) were implanted.Prior to the index procedure, the patient had presented with a large unruptured, asymptomatic aneurysm of the basilar tip with mrs of 0.An adjunctive stent was placed in the artery prior to coil treatment of the regular shaped aneurysm (15 mm high; 15 mm wide with 10 mm neck).Following coiling, residual filling of the neck was observed by angiographic assessment.No events were reported during the procedure.Patient developed l cranial nerve palsy (3rd nerve palsy) post procedure due to the size and location of the aneurysm.At the time of discharge, palsy continued to persist.The patient was discharged 2 days after the index procedure with mrs 3.The investigator indicated the palsy was moderate and related to the procedure.At the time of the 1-month follow-up mrs had dropped to 2.A ct scan showed ¿post interventional changes following stent assisted coiling of basilar apex aneurysm.These findings are unchanged from (b)(6) 2010.No acute intracranial findings¿.The patient was advised to see an ophthalmologist.At the time of the 6-month follow-up visit, the subject¿s mrs was 0, so the palsy had apparently resolved.

Manufacturer Narrative

(b)(6).Complaint conclusion: since the coils were implanted, they were not available for analysis.In addition, the lot number was not provided; therefore, a review of the manufacturing documentation could not be provided.Neurological deficit is a known potential adverse event for intracranial coils and is listed in the instructions for use (ifu) as such.The root cause of the event cannot be confirmed.Based on the information provided, there were no product malfunctions or procedural events related to the coils, therefore, no corrective actions will be taken at this time.

• Brand Name: UNKNOWN HELIPAQ CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4074129
• MDR Text Key: 20781310
• Report Number: 1226348-2014-00446
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/14/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• 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
• Date Manufacturer Received: 02/14/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR