MAUDE Adverse Event Report: UNKNOWN

Model Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Respiratory Failure (2484)

Event Date 05/18/2018

Event Type  Death  

Manufacturer Narrative

Study was published several years after the event occurred.Valve(s) were not returned.The source publication for the reported event is valentin, ramon do; patel, divya c.Do; jantz, michael a.Md; mehta, hiren j.Md; mehrad, borna md; gomez manjarres, diana c.Md the role of bronchoscopic interventions in the management of pneumothorax in interstitial lung disease, journal of bronchology & interventional pulmonology: november 17, 2020 - volume publish ahead of print - issue - doi: 10.1097/lbr.0000000000000731.All patients evaluated in the retrospective study had a bronchoscopic procedure.A total of 40 endobronchial valves were deployed with a median of 3 valves per procedure, and a total of 19 hydrogel applications were performed with a median of 2 applications per procedure.The specific svs models are not identified in the publication.The contact author listed in the publication was contacted for additional information, no information provided at time of report.Based upon the reported timeframe (october 1, 2012 to june 30, 2019, i.E.Prior to pma approval) and the use in treatment for air leak, the devices are likely hus-xx model numbers.The hus-xxx model of the spiration valve system is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs).An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough.An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.Spiration valve system use is limited to 6 weeks per prolonged air leak.As noted, the study makes reference to the analysis of ild patients with secondary pneumothorax, and thus svs valves were not used in accordance with the labeling.

Event Description

Patient developed refractory hypoxic respiratory failure within 24 hours of svs valve placement.The svs reported event is associated with a publication reporting on the results of a single center retrospective analysis of fourteen (14) patients with a diagnosis of interstitial lung disease (ild) and secondary pneumothorax admitted to the center, who underwent bronchoscopic intervention as part of the management of persistent air leak.Spiration valve system and synthetic hydrogel coseal were used for the study.The study reflects off-label use of the device.Although a patient death is noted in the publication, the publication also states that the patient ¿succumbed to underlying ild exacerbation¿ and therefore is not related to the device or device placement.

Manufacturer Narrative

Mfr report no.3004450998-2020-00044.The author of the publication was contacted to obtain additional information.This follow-up report summarizes information provided by the author and the physician who placed the device in the patient.The valve was placed to treat pneumothorax.Pre-procedure complications or contributing factors included interstitial lung disease, combined pulmonary fibrosis and emphysema.The product did not malfunction and performed as intended.The patient death was not related to the valves used nor the valve placement procedure.No model number was provided.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• MDR Report Key: 11033399
• MDR Text Key: 222311419
• Report Number: 3004450998-2020-00044
• Device Sequence Number: 1
• Product Code: OAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2020
• 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; Life Threatening