MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC PRESIDIO 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC410041230

Device Problems Entrapment of Device (1212); Difficult To Position (1467); Retraction Problem (1536); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

During coil embolization of an aneurysm at the right internal carotid artery the surgeon suspected the deltaplush coil (cpl10020330/c24291) may have been stretched while it was being retrieved and possibly pulled another coil out of the aneurysm into the microcatheter.The other coils already in the aneurysm were a presidio (pc410041230/c18185) deltaplush (cpl10025630/c23275), and another deltaplush (cpl10020630/c24227).The surgeon tried to retrieve the deltaplush into the excelsior sl 10 microcatheter (details unknown) because it was too large for the aneurysm.The surgeon noticed on the angiography monitor that one part of the coil was visible, then there was a gap and then a piece of the coil stuck in the microcatheter.The surgeon is not sure, whether the coil was stretched while it was retrieved or whether he pulled another coil out of the aneurysm into the microcatheter when he retrieved the coil that didn¿t fit.This piece of the coil couldn¿t be repositioned into the aneurysm so it emerged out of the aneurysm and protruded into the artery.The loose piece of the coil was pinned to the artery wall with a solitaire ab 5-20 stent (details unknown).Although the delay to the procedure was noted as significant, the issue did not cause any further injury to the patient.Despite being pinned to the wall of the vessel, the coil was retrieved for investigation.It is unknown if there were any other parts of the coil delivery system that were damaged.There was some resistance when advancing the coil through the microcatheter however there was no kink in the microcatheter.A one to one relationship between the coil and delivery tube verified with fluoro prior to repositioning.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The product remains implanted, and will not be returned for analysis.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4052793
• MDR Text Key: 4862085
• Report Number: 1226348-2014-00212
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2018
• Device Catalogue Number: PC410041230
• Device Lot Number: C18185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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 Age: 27 YR