MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT MINI COMPLEX FILL; CNV DCS ORBIT (HCG)

Catalog Number 637CF0615

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 01/01/2013

Event Type  Death  

Event Description

As reported via the clinical study ¿(b)(6)¿ a (b)(6)-year-old female patient with a history of hydrocephalus, acute epidural hematoma, essential hypotension, anemia, previous coil embolization for left vertebral artery aneurysm, placement of two v-p shunts and left occipital artery-posterior inferior cerebellar artery bypass surgery expired due to an unknown cause.At the time of the index procedure, coil embolization of the left intracranial vertebral artery was performed with orbit coils (637cf0925 total 3, 637cf0824, 637cf0615, 637mf0407, 637mf0306, 637mf2535, lot all unknown) assisted with an enterprise stent (enc452812/01422404).During the procedure, the jailing technique was utilized.The unruptured saccular aneurysm neck was 6.9mm, and the neck to sac ratio was 6.9mm:17.8mm.The parent vessel size diameter proximal was 3.8mm and distally was 4.0mm.Modified rankin scale (mrs) score before the procedure was 3, one week after the procedure was 3, and approximately one month after the procedure was 2.The act was 134 seconds pre anticoagulation and 291 seconds post anticoagulation.No information regarding inr, pt and ptt.The occlusion rate of the aneurysm was 100% after the procedure.At the time of the 1-year follow-up, the aneurysm neck was 6.9mm, and the neck to sac ratio was 6.9mm:18.3mm.The parent vessel size diameter proximal was 4.5mm and distally was 3.7mm.The occlusion rate of aneurysm was 90%.The mrs was 2.The 2-year follow-up was not conducted because the patient had expired.No further information or procedural images were available.

Manufacturer Narrative

Concomitant devices: prowler select plus(606-s255x, lot unknown).Chikai 200cm 0.014inch/asahi intecc.The devices were not returned for analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of enterprise lot 01422404.The device history record review also included a review of the certificate of conformance, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The device history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Since the lot number for the orbit coils was not available, a device history review could not be conducted for these devices.Based on the information provided, it is not possible to determine the cause of death; however, the patient¿s significant neurological medical history may have contributed to the death.Aneurysm recanalization after coil embolization is a known potential event and has been estimated to occur in anywhere from 5% to 38% of coiled aneurysms.Factors which may have a correlation with recanalization post coil embolization include neck size, packing density, and inflow angle.Procedural factors and vessel/aneurysm characteristics may have contributed to the reported aneurysm re-canalization.With review of the limited information, there is no indication of any device manufacturing issues related to the event.Therefore, no corrective actions will be taken.The orbit coils are now reported on different medwatch forms and this becomes report 4 of 7 related to (b)(4).Event date is unknown.

• Brand Name: TRUFILL DCS ORBIT MINI COMPLEX FILL
• Type of Device: CNV DCS ORBIT (HCG)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3725827
• MDR Text Key: 15816840
• Report Number: 1058196-2014-00116
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 637CF0615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR