MAUDE Adverse Event Report: MICROVENTION, INC. HYDROCOIL EMBOLIC SYSTEM

Lot Number 13112019

Device Problem Coiled (1098)

Patient Problems Cognitive Changes (2551); Hydrocephalus (3272)

Event Date 02/13/2015

Event Type  Injury  

Event Description

On (b)(6) 2014, pt had coiling of a 12.8 mm x 12.6 mm x 12.1 mm unruptured aneurysm with a neck of 6.0 mm using the hydrocoil embolic system.On (b)(6) 2015, the pt went to local emergency room (er) with ataxia where imaging (mri, ct) showed hydrocephalus, new dilatation of lateral ventricles and third ventricle with definite cause of this not seen, and low-density lesion seen in left thalamus which is new and likely reflects and infarct.On (b)(6) 2015, pt was again seen in er for ataxia and decreased cognitive function.Lumbar puncture was performed on (b)(6) 2015 that was negative for malignant cells but indicated high protein with diagnosis of hydrocephalus of unk etiology.Documentation never clearly describes hydrocephalus as either obstructive or communicative in any notes.Imaging was repeated on (b)(6) 2015, the pt was hospitalized and underwent right ventriculoperitoneal shunt insertion.On (b)(6)2015, the site study team was made aware of the pt's status.The site pi considered this sae an unanticipated, device-related event.The pt was discharged from the hosp on (b)(6) 2015 and reported that the ae was ongoing with no further actions planned at the time of reporting.

• Brand Name: HYDROCOIL EMBOLIC SYSTEM
• Type of Device: HYDROCOIL EMBOLIC SYSTEM
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA 92780
• MDR Report Key: 4847286
• MDR Text Key: 5871067
• Report Number: MW5043048
• Device Sequence Number: 1
• Product Code: HCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Lot Number: 13112019
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 18000 UNITS HEPARIN AT COILING PROCEDURE; 325MG LOAD DOSE DAY OF COILING PROCEDURE AND; 81MG DAILY FOR 3 MONTHS
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 80