MAUDE Adverse Event Report: MICROVENTION, INC. HYDROCOIL 10-SYSTEM COIL; EMBOLIZATION COIL

Model Number MV-00206HHS

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

Patient Problems Death (1802); Edema (1820); Paresis (1998); Visual Disturbances (2140)

Event Date 05/08/2013

Event Type  Death  

Event Description

On (b)(6) 2013, the patient was treated for a 19mm aneurysm at the bifurcation of the basilar artery and the superior cerebellar artery without incident.No harm or complication was reported.The patient was discharged on (b)(6) 2013.On (b)(6) 2013, exacerbation of the right paresis and polyopia had developed.Edema in the brain-stem around the aneurysm was observed by mri.Hemorrhage and hydrocephalus was not observed.Recanalization of the aneurysm was not observed.Steroids were administered.On (b)(6) 2013 a brain-stem hemorrhage was observed.The patient expired on (b)(6) 2013 without recovery.

Manufacturer Narrative

Sample analysis: an evaluation of the actual complaint sample could not be performed as it remains within the patient.The device history record was reviewed.No abnormal discrepancies or non-conformances were observed.We are reporting this incident as a death occurred.There does not appear to be a correlation between the device and the brain-stem hemorrhage.

• Brand Name: HYDROCOIL 10-SYSTEM COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA
• Manufacturer Contact: teri halverson ; 1311 valencia; tustin, CA 92780 ; 7142478000
• MDR Report Key: 3687836
• MDR Text Key: 4242209
• Report Number: 2032493-2014-00028
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2014

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: 09/13/2017
• Device Model Number: MV-00206HHS
• Device Lot Number: P120913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/11/2014
• 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 Weight: 56