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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BARD PERIPHERAL VASCULAR, INC. RECOVERY IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problems Filter (816); Fracture (1260); Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2020
Event Type  Injury  
Event Description

Recovery ivcf placed in 2004 found to be multiply fractures with three arms embolized to pulmonary arteries (in retrospect this had occurred by 2010 as seen on a prior ct). Remainder of filter found to be in right atrium, new since 2013. Unclear whether migration was spontaneous or related to prior instrumentation ie catheters and pt/mother not aware of any event but pt has had multiple surgeries. Filter removed from right atrium using forceps, and fragments removed from pulmonary arteries three times. Using snare. Pt doing well and discharged next day. Fda safety report id# (b)(4).

 
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Brand NameRECOVERY IVC FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
MDR Report Key10270164
MDR Text Key198878569
Report NumberMW5095505
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/13/2020 Patient Sequence Number: 1
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