MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; EMBOLIZATION COIL

Model Number 100408H2HS-V

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

Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Thrombus (2101)

Event Date 03/24/2018

Event Type  Death  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was returned with the dispenser coil, the introducer, and the pusher system; the implant was still attached to the pusher.Lead wire separation was noted in the middle of the pusher, and was damaged and kinked at the distal section close to the heater coil section, near the attachment zone.The implant was attached to the pusher system with sufficient tension.The implant's distal tip was noted to be intact.The attached implant was not damaged or kinked, and the tie-knot section was intact.An attempt was made to advance the pusher inside the introducer to replicate the complaint.The pusher advanced smoothly, until the section where the core wire was straight.At this location, friction was observed at these particular sections where the core wire had kinks.There was no train wrecking observed, or a situation where the pusher could not be advanced anymore.Based on the investigation, the returned device was noted to have mild friction issues due to the kinked core wire section at the distal end; however, the coil was still intact and not broken.The minor damage likely occurred during or after device removal,or during handling of the device for packaging and return to the manufacturer.There was no reported device malfunction.Coil loops may extend outside of the aneurysm as a result of several factors, including patient conditions and pathology, anatomical configuration, the number of coils implanted, and physician technique and treatment choices.It is unknown if the device could have contributed to the formation of thrombus.The reported details indicated the patient was given additional thrombolytics during the procedure, which could have caused or contributed to the re-bleeding of the aneurysm; however, that could not be determined from the investigation.The instructions for use (ifu) identifies thrombus and death as potential complications associated with use of the device.

Event Description

It was reported that on (b)(6) 2018, treatment was performed for a ruptured 5.5 mm mca aneurysm.While deploying the 4th embolization coil, 2-3 loops of the coil extended into the parent vessel.The coil was removed and a follow-up angiogram demonstrated thrombus in the mca branch.Tirofiban was administered.Later during the procedure, the mca became occluded and actilyse (5 mg) was given.Subsequently, the aneurysm bled, but stopped shortly afterward without intervention.A stent was implanted across the major mca branch (m3 segment to m1), which reopened the major mca branch; however, despite no delayed blood flow, the inferior mca branch became occluded.The procedure was stopped and approximately 15 minutes post-procedure, a ct scan was performed, which revealed no major sah or infarct.The patient responded and woke up after extubation, but had left-sided weakness.Two (2) hours post procedure, a re-bleed at the site of the aneurysm occurred, resulting in a massive sah.The patient died on the morning on (b)(6) 2018.

• Brand Name: HYDROSOFT HELICAL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7484995
• MDR Text Key: 107309825
• Report Number: 2032493-2018-00081
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K070656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

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: Other
• Device Expiration Date: 10/31/2019
• Device Model Number: 100408H2HS-V
• Device Lot Number: 141020N4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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: 50 YR
• Patient Weight: 75