Spiration Valve System SVS-V9-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00896506002309), received between May 17, 2019 and Apr 29, 2026 — classified as 5 deaths, 93 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 23, 2021Open, Classified

   Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

   Z-0551-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Migration

  1 OF 2 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. ON (B)(6) 2024 THE PATIENT UNDERWENT MULTIPLE SPIRATION VALVE PLACEMENT IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA. ONE 7MM VALVE WAS PLACED IN RB8, ONE 7MM VALVE WAS PLACED IN RB9, ONE 7MM VALVE WAS PLACED IN RBA10, ONE 9MM VALVE WAS PLACED IN RB 7, AND LASTLY, AN ADDITIONAL 9 MM VALVE WAS PLACED IN RB6. POST PROCEDURE THE PATIENT WAS MONITORED IN A HOSPITAL BED AND HAD A CHEST X-RAY PERFORMED. ON (B)(6) 2025, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS TREATED IN THE EMERGENCY ROOM WITH AZITHROMYCIN AND PREDNISONE AND DISCHARGED. THE EVENT WAS CONSIDERED RELATED TO THE DEVICE DUE TO VALVE MIGRATION OF THE 9MM VALVES IN RB6 AND RB7. ON (B)(6) 2025, THE 9MM VALVES IN RB6 AND RB7 WERE REMOVED DUE TO VALVE MIGRATION AND REPLACED.

  Patient problems: Dyspnea

  MAUDE report 25036574 ↗
• InjuryApr 8, 2026Adverse 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 THE PATIENT DEVELOPED PNEUMONIA IN THE VALVE-TREATED LOBE REQUIRING HOSPITALIZATION, IV ANTIBIOTICS, AND VALVE REMOVAL.

  Patient problems: Pneumonia

  MAUDE report 24816930 ↗
• InjuryMar 25, 2026Adverse 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. ON (B)(6) 2025, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION WITH THREE SVS VALVES IN THE RIGHT UPPER LOBE (RUL). THE PATIENT EXPERIENCED A LARGE RIGHT PNEUMOTHORAX POST PROCEDURE ON THAT SAME DAY, AND A CHEST TUBE WAS PLACED. ADDITIONALLY, THIS NECESSITATED REMOVAL OF THIS VALVE ON (B)(6) 2025. THE PATIENT HAS TWO REMAINING VALVES IN THE RUL. PNEUMOTHORAX IMPROVED AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED ON 4 LITERS (L) OF OXYGEN WITH IMPROVED SHORTNESS OF BREATH AND ACTIVITY. THE PATIENT HAS SINCE HAD SEVERAL FOLLOW-UP VISITS AND REPORTS AN IMPROVEMENT IN HER CONDITION. IT WAS REPORTED THAT AT THE ONE MONTH FOLLOW UP APPOINTMENT, THE PATIENT HAD SOME DISCOMFORT AROUND THE SITE OF THE INSERTION OF THE CHEST TUBE; HOWEVER, ON ASSESSMENT, THE INCISION WAS WELL-HEALED WITHOUT ANY REDNESS OR SWELLING

  Patient problems: Discomfort; Dyspnea; Pneumothorax

  MAUDE report 24691800 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  REPORT 4 OF 6. 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. ON (B)(6) 2024 THE PATIENT UNDERWENT A THERAPEUTIC BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE DURING WHICH MULTIPLE SPIRATION VALVES WERE PLACED. FOUR 9MM VALVES AND TWO 5MM VALVES WERE PLACED IN AN UNSPECIFIED LOBE/LOCATION. ON (B)(6) 2026, THE PATIENT EXPERIENCED COUGH, SHORTNESS OF BREATH AND FEVER. A SPUTUM CULTURE WAS PERFORMED WHICH IDENTIFIED VERY LIGHT GROWTH OF STENOTROPHOMONAS MALTOPHILIA. THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA, RECEIVED ANTIBIOTIC TREATMENT, AND THE ENDOBRONCHIAL VALVES WERE REMOVED. THE PATIENT IMPROVED AND WAS DISCHARGED ON AN UNSPECIFIED DATE.

  Patient problems: Pneumonia

  MAUDE report 24635595 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  REPORT 3 OF 6. 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. ON (B)(6) 2024 THE PATIENT UNDERWENT A THERAPEUTIC BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE DURING WHICH MULTIPLE SPIRATION VALVES WERE PLACED. FOUR 9MM VALVES AND TWO 5MM VALVES WERE PLACED IN AN UNSPECIFIED LOBE/LOCATION. ON (B)(6) 2026, THE PATIENT EXPERIENCED COUGH, SHORTNESS OF BREATH AND FEVER. A SPUTUM CULTURE WAS PERFORMED WHICH IDENTIFIED VERY LIGHT GROWTH OF STENOTROPHOMONAS MALTOPHILIA. THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA, RECEIVED ANTIBIOTIC TREATMENT, AND THE ENDOBRONCHIAL VALVES WERE REMOVED. THE PATIENT IMPROVED AND WAS DISCHARGED ON AN UNSPECIFIED DATE.

  Patient problems: Pneumonia

  MAUDE report 24635458 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  REPORT 1 OF 6. 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. ON (B)(6) 2024 THE PATIENT UNDERWENT A THERAPEUTIC BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE DURING WHICH MULTIPLE SPIRATION VALVES WERE PLACED. FOUR 9MM VALVES AND TWO 5MM VALVES WERE PLACED IN AN UNSPECIFIED LOBE/LOCATION. ON (B)(6) 2026, THE PATIENT EXPERIENCED COUGH, SHORTNESS OF BREATH AND FEVER. A SPUTUM CULTURE WAS PERFORMED WHICH IDENTIFIED VERY LIGHT GROWTH OF STENOTROPHOMONAS MALTOPHILIA. THE PATIENT WAS HOSPITALIZED, RECEIVED ANTIBIOTIC TREATMENT, AND THE ENDOBRONCHIAL VALVES WERE REMOVED. THE PATIENT IMPROVED AND WAS DISCHARGED ON AN UNSPECIFIED DATE.

  Patient problems: Pneumonia

  MAUDE report 24635102 ↗
• InjuryMar 4, 2026Adverse 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. THE SUBJECT (B)(6)., ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS UNDER GENERAL ANESTHESIA ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT WAS TAKEN TO AN EMERGENCY ROOM, AFTER A NEIGHBOR FOUND HER ON THE FLOOR AND UNABLE TO GET UP. AT THE HOSPITAL, DOCTORS DISCOVERED THAT SHE HAD A LARGE RIGHT PNEUMOTHORAX. THEY PLACED A CHEST TUBE TO HELP RE EXPAND THE LUNG. ON (B)(6) 2026, SHE WAS TRANSFERRED TO ANOTHER (B)(6) HOSPITAL. ON (B)(6) 2026 DOCTORS TRIED A CLAMP TRIAL TEMPORARILY CLAMPING THE CHEST TUBE TO SEE IF HER LUNG WOULD STAY EXPANDED, BUT A SMALL COLLAPSE WAS STILL SEEN ON THE CHEST X RAY. THEY REPEATED THE CLAMP TRIAL FROM (B)(6), AND THIS TIME THE X RAY SHOWED NO LUNG COLLAPSE, SO THE CHEST TUBE WAS REMOVED ON (B)(6) 2026. HOWEVER, ON (B)(6) 2026, A NEW CHEST X RAY SHOWED THAT HER LUNG HAD COLLAPSED AGAIN. ANOTHE

  Patient problems: Loss of consciousness; Pneumonia

  MAUDE report 24507865 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Loss of consciousness; Pneumothorax

  MAUDE report 24475785 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE AND 6 SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG. THE PATIENT HAD ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) APPROXIMATELY 8 DAYS AFTER VALVE PLACEMENT. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND WAS GIVEN INTRAVENOUS (IV) MEDICATION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INJURY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE. THIS REPORT IS 6 OF 6 VALVES.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 24448638 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE AND 6 SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG. THE PATIENT HAD ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) APPROXIMATELY 8 DAYS AFTER VALVE PLACEMENT. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND WAS GIVEN INTRAVENOUS (IV) MEDICATION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INJURY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE. THIS REPORT IS 5 OF 6 VALVES.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 24448631 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE AND 6 SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG. THE PATIENT HAD ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) APPROXIMATELY 8 DAYS AFTER VALVE PLACEMENT. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND WAS GIVEN INTRAVENOUS (IV) MEDICATION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INJURY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE. THIS REPORT IS 3 OF 6 VALVES.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 24448585 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE AND 6 SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG. THE PATIENT HAD ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) APPROXIMATELY 8 DAYS AFTER VALVE PLACEMENT. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND WAS GIVEN INTRAVENOUS (IV) MEDICATION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INJURY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE. THIS REPORT IS 2 OF 6 VALVES.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 24448541 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612270 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612232 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION SUBMITTED BY THE CUSTOMER.

  Patient problems: Pneumothorax

  MAUDE report 22668673 ↗
• InjuryJul 10, 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. THE SUBJECT ORA17_03_010, ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUED TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. ON (B)(6) 2025, THE SUBJECT DEVELOPED PNEUMONIA, LEADING TO HOSPITAL ADMISSION THE SAME DAY. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH SOLU-MEDROL, F

  Patient problems: Dyspnea; Loss of consciousness; Pneumonia; Respiratory Failure; Respiratory Insufficiency; Sepsis

  MAUDE report 22470955 ↗
• InjuryJul 10, 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. THE SUBJECT (B)(6), ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUED TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. ON (B)(6) 2025, THE SUBJECT DEVELOPED PNEUMONIA, LEADING TO HOSPITAL ADMISSION THE SAME DAY. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH SOLU-MEDROL, FOLLOWE

  Patient problems: Dyspnea; Loss of consciousness; Pneumonia; Respiratory Failure; Respiratory Insufficiency; Sepsis

  MAUDE report 22470811 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF SHORTNESS OF BREATH. PATIENT REPORTED HEMOPTYSIS, COUGH AND WEAKNESS SINCE BEING DISCHARGED AFTER INITIAL VALVE PLACEMENT. THE INITIALLY REPORTED AES OF HEMOPTYSIS, COPD EXACERBATION AND PNEUMONIA WERE DETERMINED TO NOT HAVE BEEN CAUSED BY THE OLYMPUS DEVICE. THE PATIENT WAS SCHEDULED FOR A REPEAT BRONCHOSCOPY DUE TO CONTINUED HEMOPTYSIS BUT SOB WORSENED PROMPTING AN ER VISIT. CXR SHOWED PERSISTENT EMPHYSEMA WITH LEFT SIDED ENDOBRONCHIAL VALVES AND LUL COLLAPSE AND INCREASED OPACITY IN THE LEFT LUNG BASE. THE PATIENT LATER HAD THE VALVES REMOVED DUE TO CONTINUED HEMOPTYSIS, LATER CLASSIFIED AS MASSIVE HEMOPTYSIS IN THE SETTING OF KNOWN CAVITARY ASPERGILLUS PNEUMONIA AND SEVERE COPD. IT WAS LATER REPORTED ON (B)(6) 2025 THAT DESPITE MULTIPLE ATTEMPTS AT CAUTERY, IR EMBOLIZATION OF THE BRONCHIAL ARTERIES, AND INHALED TXA, THE HEMOPTYSIS DID NOT ABATE AND THE PATIENT CONTINUED TO BLEED FROM MULTIPLE AREAS IN THE LEFT LUNG. THE PATIENT WAS NOT A CANDIDATE FOR SURGERY DUE TO PATIENT¿S SEVERE EMPHYSEMA. THE PATIENT WAS EXTUBATED FOR COMFORT CARE AND DECEASED THE SAME DAY.

  Patient problems: Hemoptysis

  MAUDE report 22310577 ↗
• InjuryJun 18, 2025Migration; Migration

  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. THE SUBJECT (B)(6), ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUES TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. THIS COMPLAINT PERTAINS TO THE MIGRATION ISSUE ASSOCIATED WITH LOT WS383672.

  Patient problems: Dyspnea; Respiratory Insufficiency

  MAUDE report 22283326 ↗
• InjuryJun 18, 2025Migration; Migration

  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. THE SUBJECT (B)(6), ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUES TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. THIS COMPLAINT PERTAINS TO THE MIGRATION ISSUE ASSOCIATED WITH LOT WS388855.

  Patient problems: Dyspnea; Respiratory Insufficiency

  MAUDE report 22283300 ↗
• 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 22120519 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. SIX SPIRATION VALVES WERE IMPLANTED INTO THE LEFT UPPER LOBE ON (B)(6) 2025. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT DEVELOPED A PNEUMOTHORAX FOLLOWING THE PLACEMENT OF THE VALVES WHICH WAS NOTED ON POST OP CHEST X RAY THE SAME DAY. CHEST TUBE PLACEMENT WAS PERFORMED TO TREAT THE PNEUMOTHORAX. EVENT RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY AND WAS REPORTED TO BE DOING WELL. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21939754 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. SIX ASPIRATION VALVES WERE IMPLANTED INTO THE LEFT UPPER LOBE ON (B)(6) 2025. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT DEVELOPED A PNEUMOTHORAX FOLLOWING THE PLACEMENT OF THE VALVES WHICH WAS NOTED ON POST OP CHEST X RAY THE SAME DAY. CHEST TUBE PLACEMENT WAS PERFORMED TO TREAT THE PNEUMOTHORAX. EVENT RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY, AND WAS REPORTED TO BE DOING WELL. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21939560 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. SIX SPIRATION VALVES WERE IMPLANTED INTO THE LEFT UPPER LOBE ON (B)(6) 2025. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT DEVELOPED A PNEUMOTHORAX FOLLOWING THE PLACEMENT OF THE VALVES WHICH WAS NOTED ON POST OP CHEST X RAY THE SAME DAY. CHEST TUBE PLACEMENT WAS PERFORMED TO TREAT THE PNEUMOTHORAX. EVENT RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY AND WAS REPORTED TO BE DOING WELL. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21939555 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. SIX ASPIRATION VALVES WERE IMPLANTED INTO THE LEFT UPPER LOBE ON (B)(6) 2025. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT DEVELOPED A PNEUMOTHORAX FOLLOWING THE PLACEMENT OF THE VALVES WHICH WAS NOTED ON POST OP CHEST X RAY THE SAME DAY. CHEST TUBE PLACEMENT WAS PERFORMED TO TREAT THE PNEUMOTHORAX. EVENT RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY, AND WAS REPORTED TO BE DOING WELL. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21939553 ↗