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

Catalog Number CPL10020330

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  Injury  

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 & delivery tube verified with fluoro prior to repositioning.

Manufacturer Narrative

The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.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.

Manufacturer Narrative

Revised investigational summary: it was confirmed that the returned deltaplush coil was stretched at the proximal section, and the distal section of the coil received damage that caused spacing between the primary windings secondary shaping.The coil did not separate.Although the root cause of the stretching and distal coil damage cannot be conclusively determined, based on the information received from the customer and product analysis, the most likely cause of the coil damage occurred when the coil became entangled with the previously implanted coils that were inside the aneurysm during retrieval of the coil.When the stretched coil was removed, it pulled the previously implanted coil out into the parent vessel where it was then attached to the vessel wall.For optimum product performance and to prevent potential complications, the instructions for use (ifu) outlines: ¿caution: always perform fluoroscopic verification of detachment prior to withdrawing the dpu wire fully.Failure to do so may lead to an embolic complication.Caution: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ it further outlines ¿caution: if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.¿ since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

Manufacturer Narrative

Also in the follow up type in the previous follow up report, "additional information", and "device evaluation" should have been checked instead of "correction." the information is based on device evaluation.

• Brand Name: DELTAPLUSH - 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 (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4044447
• MDR Text Key: 4902218
• Report Number: 1226348-2014-00194
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083646
• 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,Followup
• Report Date: 08/05/2014

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 Expiration Date: 02/18/2019
• Device Catalogue Number: CPL10020330
• Device Lot Number: C24291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/23/2014; 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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): Required Intervention
• Patient Age: 27 YR