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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLCANO CORPORATION CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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VOLCANO CORPORATION CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 7024
Device Problems Partial Blockage (1065); Occlusion Within Device (1423)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 03/20/2014
Event Type  Injury  
Event Description

Crux vcf was initially implanted on (b)(6) 2014 and the occlusion was confirmed on (b)(6) 2014. Patient history included trauma with intracranial bleeding. The patient was unable to be anticoagulated due to the intracranial bleed. At the time of the crux vcf insertion, the patient had a right common iliac dvt as well as bilateral soliel vein dvt. The physician stated that the ivc diameter was about 17mm. The crux vcf was deployed via the left femoral vein approach. On (b)(6) 2014, the patient developed dvt in the left iliac vein which continued into the ivc and crux vcf all the way up to the level of the renal veins. This dvt was diagnosed via venous duplex ultrasound. The patient then had a venogram completed to assess the extent of the thrombosis. The physician stated that the ivc and crux vcf showed no flow and was occluded. Volcano clinical rep reported that the filter was removed and another company filter was implanted. The date of crux retrieval is currently unknown.

 
Manufacturer Narrative

(b)(4). This device was not returned to the manufacturer and serial and lot # of the filter system was not available to be reported by the clinical staff. Without this information, manufacturing documentation for this device was not able to be reviewed to confirm the device met all quality and manufacturing release criteria. In addition, without this information we are unable to confirm that to date, if any other complaints have been reported for this failure mode within this device's lot. Since the physician reported the vessel to be occluded and that intervention was required (filter retrieval) this report is being submitted due to an abundance of caution. A supplemental report will be submitted when the manufacturer's scientific affairs department completes the clinical assessment for this case.

 
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Brand NameCRUX VENA CAVA FILTER SYSTEM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
VOLCANO CORPORATION
rancho cordova CA
Manufacturer Contact
denise stearns
3721 valley centre dr.
suite 500
rancho cordova, CA 95670
8587204178
MDR Report Key3778218
MDR Text Key4434261
Report Number2939520-2014-00029
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7024
Device Catalogue Number7024
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/21/2014
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 TREATMENT DATA
Date Received: 04/16/2014 Patient Sequence Number: 1
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