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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE

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VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE Back to Search Results
Model Number SVS-V7-00
Device Problem Difficult to Remove (1528)
Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)
Event Date 07/01/2022
Event Type  Death  
Event Description
Patient was treated for emphysema.Spiration valves were placed.Patient clinically worse post procedure and was optimized medically.Patient was found to have persistent lul expansion.Repeat bronchoscopy was performed approximately one month post procedure.Clinician indicated not all valves visualized consistent with migration and valve was replaced.Patient continued to worsen clinically.Decision was made to remove valves.Approximately 5 months post procedure, the decision was made to remove valves due to patient clinical regression.Lingular segmental valve was removed without incident.Anterior segmental valve (svs-v7-00) with significant granulation tissue was also removed.Aggressive attempts at removal resulted in significant airway bleeding leading to airway compromise and subsequent cardiac arrest requiring extracorporeal support.Patient passed away.
 
Manufacturer Narrative
Physician reported the event was not device related but technique related.Device not returned to manufacturer.
 
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Brand Name
VALVE IN CARTRIDGE, 7MM
Type of Device
SPIRATION VALVE
Manufacturer Contact
sophia rubalcaba
6675 185th ave ne
redmond, WA 98052
4256365470
MDR Report Key15176522
MDR Text Key297352114
Report Number3004450998-2022-00013
Device Sequence Number1
Product Code NJK
UDI-Device Identifier00896506002279
UDI-Public896506002279
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PMA P180007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/05/2022
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 Model NumberSVS-V7-00
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received08/05/2022
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 Number1
Patient Outcome(s) Required Intervention; Hospitalization; Death;
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