MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Catalog Number ENC452800

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

Initially, an unspecified guiding catheter(fubuki 6fr/asahi intecc, type unknown) was navigated in the right internal carotid artery and an unspecified prowler select plus(606-s255x, lot unknown) was delivered over an unspecified guidewire(chikai 18/asahi intecc) to the m2 segment of right middle cerebral artery.During that time, it was noted that the physician experienced great difficulties delivering the microcatheter due to the heavy tortuousity of the carotid siphon.Then he delivered an unspecified presidio (pc4180933-30, lot unknown) into the aneurysm through another microcatheter(excelsior 1018/stryker, type 90-degree angle).As the physician was planned the coil embolisation after vrd deployment, the presidio was kept without detachment into the target aneurysm.Later on, the event happened during enterprise vrd (enc452800, lot unknown) deployment.The physician advanced the reference marker of the delivery wire of the vrd until the hub of the microcatheter and withdrew the introducer from the microcatheter hub.After withdrawal, although he advanced the delivery wire into the microcatheter, he experienced severe resistance and rasped feeling.As the repositioning of the microcatheter was required, he slightly pulled it back to the correct position but it migrated from m2 segment of middle cerebral artery to cavernous portion of internal carotid artery.Thus he discontinued the vrd deployment.Then, both the vrd and the prowler select plus were safely removed as a unit from the patient.The vrd was then removed from the microcatheter and it is unknown whether the same microcatheter was used later in the procedure.Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.

Manufacturer Narrative

It is unknown if the presidio was detached and placed into the target aneurysm after withdrawal of the vrd.The procedure was coil embolisation assisted with the enterprise vrd for right internal carotid-posterior communicating artery aneurysm that was heavily tortuous but the level of calcification was unknown.The patient was a female of unknown age.Access was obtained from femoral artery.Concomitant medical products: guiding catheter(fubuki 6fr/asahi intecc, type unknown); prowler select plus microcatheter (606-s255x, lot unknown); guidewire (chikai 18/asahi intecc); presidio coil (pc4180933-30, lot unknown); other microcatheter (excelsior 1018/stryker, 90-degree angle).The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

One non sterile enterprise vascular reconstruction device (vrd) and delivery system was received coiled in a plastic bag.The unit was inspected and no damages were found.The delivery wire coil tip (including stent) was found inside introducer tube.The stent and coil tip were observed under microscope magnification and no damages/anomalies were noted.Functional test was performed per procedure.The enterprise was inserted and advanced through a microcatheter.No resistance/friction was felt while advancing delivery wire.The enterprise (including the stent) passed completely through microcatheter.A lab sample microcatheter was used for the functional testing since the involved prowler select plus microcatheter was not returned for analysis.The device history record reviews could not be performed as the lot numbers of the enterprise and prowler select plus are not available.Inability to insert the returned enterprise system through a compatible microcatheter was not confirmed with functional testing; the device performed as designed.The concomitant prowler select plus was not returned for analysis; therefore no conclusion can be made regarding its impact on the reported event.However, based on the reported difficulty advancing the prowler select plus through the tortuous anatomy, it is possible that vessel characteristics may have contributed to the event.Therefore, no corrective actions will be taken at this time.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: matthew king ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 3565918
• MDR Text Key: 4046504
• Report Number: 1058196-2014-00010
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H60001
• 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: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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