Spiration Valve System SVS-V6-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00896506002293), received between Jul 24, 2019 and Jul 7, 2025 — classified as 1 death, 30 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (P180007); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT AFTER HAVING VALVES REPLACED, THE PATIENT DEVELOPED SEVERE DYSPNEA AND HYPOXEMIC RESPIRATORY FAILURE. A CHEST X-RAY SHOWED LARGE BASILAR PNEUMOTHORAX SECONDARY TO ATELECTASIS OF THE TARGET LOBE AND A CHEST TUBE WAS INSERTED.

  Patient problems: Pneumothorax

  MAUDE report 22411554 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING.

  Patient problems: Pneumothorax

  MAUDE report 22411550 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING.

  Patient problems: Pneumothorax

  MAUDE report 22411540 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT AFTER HAVING VALVES REPLACED, THE PATIENT DEVELOPED SEVERE DYSPNEA AND HYPOXEMIC RESPIRATORY FAILURE. A CHEST X-RAY SHOWED LARGE BASILAR PNEUMOTHORAX SECONDARY TO ATELECTASIS OF THE TARGET LOBE AND A CHEST TUBE WAS INSERTED.

  Patient problems: Pneumothorax

  MAUDE report 22411530 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT AFTER HAVING VALVES REPLACED, THE PATIENT DEVELOPED SEVERE DYSPNEA AND HYPOXEMIC RESPIRATORY FAILURE. A CHEST X-RAY SHOWED LARGE BASILAR PNEUMOTHORAX SECONDARY TO ATELECTASIS OF THE TARGET LOBE AND A CHEST TUBE WAS INSERTED.

  Patient problems: Pneumothorax

  MAUDE report 22411488 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT AFTER HAVING VALVES REPLACED, THE PATIENT DEVELOPED SEVERE DYSPNEA AND HYPOXEMIC RESPIRATORY FAILURE. A CHEST X-RAY SHOWED LARGE BASILAR PNEUMOTHORAX SECONDARY TO ATELECTASIS OF THE TARGET LOBE AND A CHEST TUBE WAS INSERTED.

  Patient problems: Pneumothorax

  MAUDE report 22411466 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT AFTER HAVING VALVES REPLACED, THE PATIENT DEVELOPED SEVERE DYSPNEA AND HYPOXEMIC RESPIRATORY FAILURE. A CHEST X-RAY SHOWED LARGE BASILAR PNEUMOTHORAX SECONDARY TO ATELECTASIS OF THE TARGET LOBE AND A CHEST TUBE WAS INSERTED.

  Patient problems: Pneumothorax

  MAUDE report 22411434 ↗
• InjuryMay 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Chest Pain; Hemoptysis; Pneumothorax

  MAUDE report 22120544 ↗
• InjuryMay 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Chest Pain; Hemoptysis; Pneumothorax

  MAUDE report 22120532 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21607730 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21607720 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THERE HAD BEEN REPORTS OF PATIENTS WHO HAD DIED BUT NONE OF THEM WERE DUE TO THE DEVICE, BUT RATHER DUE TO THE PATIENT'S CONDITIONS. THE DEVICE WAS INSIDE THE PATIENT BUT IT WAS NOT THE CAUSE OF DEATH. THERE WERE NO FURTHER INFORMATION RECEIVED SPECIFIC FOR THIS PATIENT.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21607715 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT MULTIPLE SPIRATION VALVE PLACEMENT IN THE RIGHT UPPER LOBE UNDER GENERAL ANESTHESIA. ONE 6MM VALVE WAS PLACED IN RB1B, ONE 6MM VALVE WAS PLACED IN RB1A, ANOTHER 7MM VALVE WAS PLACED IN RB2 AND LASTLY, ONE 9 MM VALVE WAS PLACED IN RB3. POST PROCEDURE THE PATIENT WAS MONITORED IN A HOSPITAL BED AND HAD A CHEST X-RAY PERFORMED. ON (B)(6) 2024. THE PATIENT REQUIRED HOSPITALIZATION AND CHEST TUBE PLACEMENT DUE TO A RIGHT TENSION PNEUMOTHORAX. THE FOLLOWING DAY, THE CHEST TUBE WAS REMOVED WITHOUT COMPLICATION. TWO DAYS LATER, A FOLLOW UP CHEST RAY WAS PERFORMED AND INDICATED NO PNEUMOTHORAX. THE EVENT WAS RELATED TO THE DEVICES BUT NOT THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21169646 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT MULTIPLE SPIRATION VALVE PLACEMENT IN THE RIGHT UPPER LOBE UNDER GENERAL ANESTHESIA. ONE 6MM VALVE WAS PLACED IN RB1B, ONE 6MM VALVE WAS PLACED IN RB1A, ANOTHER 7MM VALVE WAS PLACED IN RB2 AND LASTLY, ONE 9 MM VALVE WAS PLACED IN RB3. POST PROCEDURE THE PATIENT WAS MONITORED IN A HOSPITAL BED AND HAD A CHEST X-RAY PERFORMED. ON (B)(6) 2024, THE PATIENT REQUIRED HOSPITALIZATION AND CHEST TUBE PLACEMENT DUE TO A RIGHT TENSION PNEUMOTHORAX. THE FOLLOWING DAY, THE CHEST TUBE WAS REMOVED WITHOUT COMPLICATION. TWO DAYS LATER, A FOLLOW UP CHEST RAY WAS PERFORMED AND INDICATED NO PNEUMOTHORAX. THE EVENT WAS RELATED TO THE DEVICES BUT NOT THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21169481 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2024. A TOTAL OF FOUR ASPIRATION VALVES WERE PLACED IN THE RIGHT LOWER LOBE; TWO 7MM (SVS-V7-00) VALVES WERE PLACED ONE EACH AT RB7+8 AND RB6, ONE 9MM (SVS-V9-00) WAS PLACED AT RB9+10 AND THE FOURTH VALVE (SVS-V6-00) WAS PLACED AT A VARIANT LOCATION. THE PATIENT HAD A POST PROCEDURE X-RAY AND WAS ADMITTED TO A MONITORED HOSPITAL BED. ON (B)(6) 2024, THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE VALVE TREATED LOBE. AN 18F CHEST TUBE WAS PLACED IN INTERVENTIONAL RADIOLOGY UNDER COMPUTED TOMOGRAPHY (CT) GUIDANCE IN THE RIGHT LUNG. THE PATIENT REMAINED IN THE HOSPITAL AND THE EVENT WAS REPORTED TO BE ON-GOING BUT PATIENT CONDITION STABLE AT THE TIME OF THIS REPORT. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES BUT NOT THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 20867969 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT ENDOBRONCHIAL VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2023. ONE 7MM VALVE (SVS-V7-00) WAS PLACED AT LB9+10 AND A SECOND 7MM VALVE (SVS-V7-00) WAS PLACED AT LB7+8. A THIRD 7 MM VALVE (SVS-V7-00) WAS INITIALLY PLACED AT LB6, HOWEVER FOLLOWING VISUALIZATION FOR PLACEMENT AND FIT ACCORDING TO THE LABELING, THE VALVE WAS REMOVED AND REPLACED WITH A 6MM VALVE (SVS-V6-00) AT LB6. AGAIN, FOLLOWING VISUALIZATION FOR FIT, THE 6MM VALVE WAS REMOVED AND ANOTHER 6MM VALVE (SVS-V6-00) WAS PLACED AT LB6 AND REMAINED IN THE PATIENT. A TOTAL OF THREE SPIRATION VALVES REMAINED PLACED IN THE PATIENT'S LEFT LOWER LOBE (ONE 7MM AT LB9+10, ONE 7MM AT LB7+8 AND ONE 6MM AT LB6). APPROXIMATELY ONE YEAR LATER (B)(6) 2024, THE PATIENT WAS HOSPITALIZED FOR PULMONARY ABSCESS IN THE LEFT LOWER LUNG (I.E., IN THE VALVE TREATED LOBE). THE PATIENT WAS TREATED WITH ANTIBIOTICS AND COMPUTED TOMOGRAPHY OF THE THORAX WAS OBTAINED. SURGICAL INTERVENTION TO REMOVE THE THREE VALVES FROM THE LEFT LOWER LOBE OCCURRED ON (B)(6)2024. THE PULMONARY ABSCESS RESOLVED WITHOUT SEQUELAE, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2024. THE EVENT WAS REPORTED TO BE RELATED TO THE DEVICE RE

  Patient problems: Abscess; Pneumonia

  MAUDE report 20153314 ↗
• InjuryJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA. TWO VALVES WERE PLACED, ONE SVS-V9-00 AND ONE SVS-V6-00. PATIENT WAS REPORTED TO HAVE DONE WELL POST PROCEDURE. ON (B)(6) 2024, APPROXIMATELY FOUR YEARS POST VALVE PLACEMENT PROCEDURE, THE PATIENT PRESENTED WITH HEMOPTYSIS. A BRONCHOSCOPIC PROCEDURE WAS SUBSEQUENTLY PERFORMED TO EVALUATE THE PATIENT. DURING THE BRONCHOSCOPIC PROCEDURE, THE VALVE MEMBRANES WERE OBSERVED TO BE DETACHED FROM THE STRUT AND AN ABSCESS WITH EVIDENCE OF INFECTION SURROUNDING THE VALVES WAS OBSERVED. THE SOURCE OF THE ABSCESS WAS NOTED TO BE A POST OBSTRUCTIVE INFECTION. CULTURES OF THE AREA WERE PERFORMED; HOWEVER RESULTS WERE NOT PROVIDED. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA IN THE VALVE TREATED LOBE. THE TWO VALVES WERE REMOVED (DATE OF REMOVAL UNKNOWN). PATIENT WAS HOSPITALIZED FOR 2 WEEKS AND WAS RELEASED TO HOME ON A COURSE OF ANTIBIOTICS. IN THE SIX TO TWELVE MONTHS PRIOR TO THE EVENT, THE PATIENT WAS REPORTED TO HAVE HAD A HISTORY OF RECURRENT RESPIRATORY INFECTIONS AND HAD BEEN HOSPITALIZED PRIOR TO THE VALVE REMOVAL PROCEDURE.

  Patient problems: Hemoptysis; Pneumonia; Unspecified Infection

  MAUDE report 19464357 ↗
• InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PARTICIPATING IN THE SVS POST APPROVAL STUDY UNDERWENT VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2024. THE PHYSICIAN PLACED A TOTAL OF FOUR SPIRATION VALVES ONE SVS-V9-00 AT RB4+RB5, ONE SVS-V7-00 AT RB3, ONE SVS-V6-00 AT RB1 AND ONE SVS-V9-00 AT RB2. ON (B)(6) 2024, THE PATIENT EXPERIENCED MILD COPD EXACERBATION IN THE VALVE TREATED LOBE REQUIRING TREATMENT AND HOSPITALIZATION. THE COPD EVENT WAS REPORTED TO BE RELATED TO THE INITIAL VALVE PLACEMENT AND PROCEDURE. THE PATIENT WAS TREATED EMPIRICALLY FOR COPD EXACERBATION WITH SOLUMEDROL, RTC DUONEBS, AND HOME INHALERS. IN ADDITION, THE PATIENT WAS EMPIRICALLY TREATED WITH CEFEPIME FOR POSSIBLE HOSPITAL ACQUIRED PNEUMONIA. PATIENT REQUIRED HIGH-FLOW NASAL CANULA, GRADUALLY HYPOXIA IMPROVED AND WAS WEANED BACK TO HOME WITH 1-2L NASAL CANULA. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED WITH PREDNISONE TAPER 30 MG EVERY DAY FOR 2 DAYS, 20 MG EVERY DAY FOR 2 DAYS, THEN 10 MG EVERY DAY FOR 2 DAYS. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR CONTINUED TREATMENT OF MILD COPD EXACERBATION. THE PHYSICIAN SUSPECTED IT WAS CAUSED BY VIRAL UPPER RESPIRATORY INFECTION (URI), ALTHOUGH THE RESP

  Patient problems: Respiratory Insufficiency

  MAUDE report 19442069 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF EMPHYSEMA ON (B)(6) 2024. THE PHYSICIAN PLACED THREE SPIRATION VALVES (1X SVS-V6-00, 1X SVS-V7-00, AND 1X SVS-V9-00). THE PATIENT EXPERIENCED A PNEUMOTHORAX IMMEDIATELY POST PLACEMENT PROCEDURE AFTER EXTUBATING. THE PATIENT WAS RE-INTUBATED, AND A FOLLOW UP CHEST X-RAY WAS TAKEN. A CHEST TUBE WAS THEN PLACED.

  Patient problems: Pneumothorax

  MAUDE report 18809805 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S CULTURE TEST RESULTS CAME BACK NEGATIVE FOR PNEUMONIA. PATIENT WAS SEEN BY PHYSICIAN 28 DAYS POST HOSPITAL DISCHARGE ((B)(6) 2023). THERE WAS NO EVIDENCE OF AN AIR LEAK. COMPUTED TOMOGRAPHY (CT) CONFIRMED PNEUMOTHORAX RESOLUTION. THE HEIMLICH VALVE (NOT A GYRUS PRODUCT) WAS LEFT IN PLACE BUT WAS SUBSEQUENTLY REMOVED 5 DAYS LATER ((B)(6) 2023).

  Patient problems: Pneumothorax

  MAUDE report 18145703 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT FOR THE TREATMENT OF EMPHYSEMA. THE PATIENT WAS PLACED ON GENERAL ANESTHESIA AND THE LEFT LOWER LOBE WAS TREATED. A TOTAL OF THREE VALVES (2X SVS-V7-00, SVS-V6-00) WERE SUCCESSFULLY PLACED IN THE LEFT LOWER LOBE (7MM IN LB9+10, 7MM IN LB7+8, AND 6MM IN LB6). DURING THE SPIRATION VALVE PLACEMENT PROCEDURE, THE PHYSICIAN TREATED THE LAST AIRWAY (LB6) TO BE OCCLUDED WITH A 7MM VALVE. THE PHYSICIAN FELT THE SIZE WAS NOT IDEAL FOR THE LB6 AIRWAY AND IN ACCORDANCE WITH THE LABELING REMOVED IT, REPLACING IT WITH A 6MM VALVE. THE PLACEMENT OF THIS VALVE DID NOT SATISFY THE PHYSICIAN, AND AGAIN IN ACCORDANCE WITH THE LABELING SUBSEQUENTLY REMOVED THIS VALVE AS WELL. IT WAS REPLACED WITH ANOTHER 6MM VALVE WHICH SUCCESSFULLY OCCLUDED LB6. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS OBSERVED POST OPERATIVELY. ON THE SAME DAY, A POST PROCEDURE CHEST X-RAY SHOWED THE PATIENT DEVELOPED PNEUMOTHORAX REQUIRING CHEST TUBE PLACEMENT EXTENDING HOSPITALIZATION. THREE DAYS LATER THE PNEUMOTHORAX RESOLVED AND CHEST TUBE WAS REMOVED. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE. THIS EVENT IS BEING REPORTED FOR THE PNEUMOTHORAX WHICH REQUIRED CHEST

  Patient problems: Pneumothorax

  MAUDE report 17552950 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE SPIRATION VALVES (1X SVS-V6-00, 2X SVS-V7-00) WERE SUCCESSFULLY PLACED IN PATIENT'S RIGHT UPPER LUNG FOR THE TREATMENT OF EMPHYSEMA (B)(6) 2023. PATIENT EXPERIENCED PNEUMOTHORAX IN THE VALVE TREATED LOBE ON (B)(6) 2023 AND RETURNED TO HOSPITAL. CHEST TUBE WAS PLACED. PATIENT RECOVERED FROM PNEUMOTHORAX. CHEST TUBE WAS REMOVED AND PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 16535021 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT THEY HAD FOUR SPIRATION VALVES PLACED (1X SVS-V7-00, 2X SVS-V9-00, AND 1X SVS-V6-00) FOR THE TREATMENT OF EMPHYSEMA (LEFT LUNG). PATIENT REPORTED CHEST TRAUMA AND SHORTNESS OF BREATH FOLLOWING A CAR ACCIDENT APPROXIMATELY FIVE MONTHS AFTER THE PLACEMENT PROCEDURE. PATIENT CONTACTED HEALTHCARE PROVIDER AND RETURNED FOR SUBSEQUENT MEDICAL EVALUATION. CHEST X-RAY AND CT SCAN PERFORMED INDICATED THAT THE VALVES REMAINED IN PLACE. CLINICIAN PERFORMED A FOLLOW-UP BRONCHOSCOPY AND CONFIRMED ALL FOUR VALVES WERE IN THE ORIGINAL POSITION AND NO VALVES EXHIBITED ANY DAMAGE. CLINICIAN INDICATED THERE WAS TISSUE GRANULATION AND CLINICIAN OPTED TO REMOVE ALL FOUR VALVES. PATIENT RETURNED TO THE HOSPITAL AFTER THE BRONCHOSCOPY FOR VALVE REMOVAL AND WAS ADMITTED FOR TREATMENT OF PNEUMONIA.

  Patient problems: Pneumonia

  MAUDE report 12849625 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BLVR PROCEDURE. A TOTAL OF 5 SPIRATION VALVES WERE PLACED IN THE RUL AND RML. ALL SEGMENTS WERE TREATED. THREE SVS-V9-00 VALVES (ONE IN RB1, ONE IN RB3A, AND ONE IN THE RML), ONE SVS-V6-00 (IN RB3B), AND ONE SVS-V7-00 (ONE IN RB2) WERE PLACED. FIVE MINUTES POST PROCEDURE, PATIENT EXHIBITED PNEUMOTHORAX AND SIGNIFICANT ATELECTASIS IN THE TREATED LOBE. THE SVS-V9-00 VALVE PLACED IN THE RML WAS REMOVED AND THE PNEUMOTHORAX WAS TREATED BY CHEST TUBE PLACEMENT. THE PATIENT HOSPITAL STAY WAS EXTENDED (9 DAYS) FOR PATIENT RECOVERY.

  Patient problems: Pneumothorax

  MAUDE report 12237132 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR SEVERE EMPHYSEMATOUS LUNGS. PATIENT HAD TWO PREVIOUS ELVR PROCEDURES WHERE ANOTHER MANUFACTURER¿S VALVES WERE PLACED IN THE RUL. IN THE THIRD PROCEDURE, THE PATIENT UNDERWENT REMOVAL OF TWO PREVIOUSLY PLACED VALVES AND PLACEMENT OF TWO SPIRATION VALVES, ONE 6MM AND ONE 9MM. PNEUMOTHORAX OCCURRED IMMEDIATELY AFTER THE PROCEDURE IN THE LOBE ADJACENT TO THE TARGET LOBE. A CHEST TUBE WAS PLACED, AND THE PNEUMOTHORAX RESOLVED AFTER EIGHT DAYS.

  Patient problems: Pneumothorax

  MAUDE report 11017100 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P180007. One submission often covers many models, so check the product and lot details in each record.

• Z-0551-2022 · Dec 23, 2021 · Open, Classified
  Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00