SPACEOAR VUE SYSTEM
Report
- Report Number
- 2124215-2024-24058
- Event Type
- Death
- Date Received
- April 23, 2024
- Date of Event
- March 14, 2024
- Report Date
- August 8, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OVB
- UDI-DI
- 00864661000140
- PMA / PMN Number
- K182971
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: BLOCK B5 AND B7 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 06, 2024. CORRECTION: BLOCK B7 HAS BEEN UPDATED ACCORDING TO THE INFORMATION AVAILABLE OF THE PATIENT WHO DIED. ADDITIONAL INFORMATION: BLOCK B5, B7 AND H6 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION. BLOCK B2: DATE OF DEATH: THIS DATE HAS BEEN ESTIMATED TO (B)(6) 2024, BASED ON THE DATE THE PATIENT RECEIVED THE SPACEOAR AND WAS READMITTED TO THE HOSPITAL. BLOCK B7: OTHER RELEVANT HISTORY: TWO PATIENTS WERE NOTED TO HAVE RECEIVED SPACEOAR ON THE SAME DAY. IT IS UNCLEAR AT THE TIME OF THIS REPORT WHETHER THIS PATIENT HISTORY BELONGS TO THIS DECEASED PATIENT OR THE SECOND PATIENT WITH NO DEVICE OR PATIENT COMPLICATIONS. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.
BLOCK B2: DATE OF DEATH: THIS DATE HAS BEEN ESTIMATED TO (B)(6) 2024, BASED ON THE DATE THE PATIENT RECEIVED THE SPACEOAR AND WAS RE ADMITTED TO THE HOSPITAL. BLOCK B7: OTHER RELEVANT HISTORY: TWO PATIENTS WERE NOTED TO HAVE RECEIVED SPACEOAR ON THE SAME DAY. IT IS UNCLEAR AT THE TIME OF THIS REPORT WHETHER THIS PATIENT HISTORY BELONGS TO THIS DECEASED PATIENT OR THE SECOND PATIENT WITH NO DEVICE OR PATIENT COMPLICATIONS. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.
ADDITIONAL INFORMATION: BLOCK B5, B7 AND H6 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION. BLOCK B2: DATE OF DEATH: THIS DATE HAS BEEN ESTIMATED TO (B)(6) 2024, BASED ON THE DATE THE PATIENT RECEIVED THE SPACEOAR AND WAS RE ADMITTED TO THE HOSPITAL. BLOCK B7: OTHER RELEVANT HISTORY: TWO PATIENTS WERE NOTED TO HAVE RECEIVED SPACEOAR ON THE SAME DAY. IT IS UNCLEAR AT THE TIME OF THIS REPORT WHETHER THIS PATIENT HISTORY BELONGS TO THIS DECEASED PATIENT OR THE SECOND PATIENT WITH NO DEVICE OR PATIENT COMPLICATIONS. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA. IT WAS A SUCCESSFUL PROCEDURE. AFTER THE PROCEDURE, ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO UNSPECIFIED HEALTH CONCERNS. THE REASON FOR HOSPITALIZATION WAS NOTED TO BE UNRELATED TO THE USE OF SPACEOAR VUE. THE PATIENT DIED ON UNKNOWN DATE. ACCORDING TO THE PLACING TEAM, THE EVENT AND SUBSEQUENT PATIENT DEATH WAS DEEMED UNLIKELY TO BE RELATED TO THE PLACING PROCEDURE AND THE SPACEOAR VUE DEVICE. NO AUTOPSY HAS BEEN RECEIVED TO DATE. THE RELATION TO THE SPACEOAR VUE DEVICE AND PLACING PROCEDURE TO CAUSE OF DEATH WAS UNCONFIRMED. ADDITIONAL INFORMATION: IT WAS FURTHER REPORTED THAT ONE OF THE PATIENT'S RECEIVED 20 CC OF 1 - 2% LIDOCAINE AND THE OTHER RECEIVED ONLY 10 CC. AFTER THE PROCEDURE WAS COMPLETED THE PATIENT WHO DIED, STATED THAT HE FELT LIGHT-HEADED, THEN THE PATIENT STATED THAT HE WANTED TO VOMIT, HOWEVER HE DID NOT. THE PATIENT LAY DOWN AND WENT INTO CARDIAC ARREST, THE BLOOD PRESSURE WAS NORMAL BUT THE O2 SATURATION REMAINED AT 84%. PARAMEDICS WERE CALLED AND RESUSCITATION MEASURES WERE PERFORMED, THE PATIENT REGAINED CIRCULATION AND WAS SEND TO THE MAIN HOSPITAL IN THE CITY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT SHOWED THE HYDROGEL WAS IN PLACE. THE PATIENT DIED NEXT DAY, AND AUTOPSY WAS PERFORMED, THE EXAM REVEALED THAT THE PATIENT HAD CORONARY ARTERIES OCCLUDED, IT WAS ALSO NOTED THAT THIS PATIENT HAD BEEN REFERRED TO CARDIOLOGY MORE THAN ONCE, AUTOPSY ALSO SHOWED MICROSCOPIC AMOUNTS OOF HYDROGEL IN THE PROSTATIC AND PULMONARY VASCULATURE. THE AUTOPSY DID NO ENLIST ONE SPECIFIC CAUSE OF DEATH BUT RATHER LISTED CORONARY ARTERY BLOCKAGE AND PULMONARY EMBOLI OOF THE HYDROGEL UNDER CAUSE OOF DEATH SECTION. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS LIKELY MULTIFACTORIAL, AND THE PROCEDURE SOMEHOW CONTRIBUTE THE EVENTS. ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE AUTOPSY REPORTED NOTED THE ATHEROSCLEROSIS AND COMORBID CONDITIONS, THE REPORTED INCLUDED 95% OCCLUSION ON THE LEFT MAIN CORONARY ARTERY 80% OCCLUSION OF THE LEFT MAIN CORONARY ARTERY, 95% OCCLUSION OF THE RIGHT MAIN CORONARY ARTERY. THE PHYSICIAN ALSO TALKED ABOUT THIS CASE TO A PATHOLOGIST, THE PATHOLOGIST EXPLAINED THAT HEALTHY PATIENTS COULD HAVE MICROEMBOLISM WITHOUT SYMPTOMS, HOWEVER PATIENT WITH CARDIOVASCULAR PROBLEMS AS THIS PATIENT COULD BE A SIGNIFICANT FACTOR. THE CAUSE OF DEATH STILL LIKELY MULTIFACTORIAL RELATED TO THE PATIENT'S DISEASE AND PROCEDURE. THIS INFORMATION REINFORCE THAT THE CAUSE OF DEATH WAS MULTIFACTORIAL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA. IT WAS A SUCCESSFUL PROCEDURE. AFTER THE PROCEDURE, ON (B)(6) 2024 THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO UNSPECIFIED HEALTH CONCERNS. THE REASON FOR HOSPITALIZATION WAS NOTED TO BE UNRELATED TO THE USE OF SPACEOAR VUE. THE PATIENT DIED ON UNKNOWN DATE. ACCORDING TO THE PLACING TEAM, THE EVENT AND SUBSEQUENT PATIENT DEATH WAS DEEMED UNLIKELY TO BE RELATED TO THE PLACING PROCEDURE AND THE SPACEOAR VUE DEVICE. NO AUTOPSY HAS BEEN RECEIVED TO DATE. THE RELATION TO THE SPACEOAR VUE DEVICE AND PLACING PROCEDURE TO CAUSE OF DEATH WAS UNCONFIRMED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS IMPLANTED DURING A SPACEOAR VUE PLACEMENT PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA. IT WAS A SUCCESSFUL PROCEDURE. AFTER THE PROCEDURE, ON (B)(6) 2024 THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO UNSPECIFIED HEALTH CONCERNS. THE REASON FOR HOSPITALIZATION WAS NOTED TO BE UNRELATED TO THE USE OF SPACEOAR VUE. THE PATIENT DIED ON UNKNOWN DATE. ACCORDING TO THE PLACING TEAM, THE EVENT AND SUBSEQUENT PATIENT DEATH WAS DEEMED UNLIKELY TO BE RELATED TO THE PLACING PROCEDURE AND THE SPACEOAR VUE DEVICE. NO AUTOPSY HAS BEEN RECEIVED TO DATE. THE RELATION TO THE SPACEOAR VUE DEVICE AND PLACING PROCEDURE TO CAUSE OF DEATH WAS UNCONFIRMED. ADDITIONAL INFORMATION IT WAS FURTHER REPORTED THAT ONE OF THE PATIENT'S RECEIVED 20 CC OF 1 - 2% LIDOCAINE AND THE OTHER RECEIVED ONLY 10 CC. AFTER THE PROCEDURE WAS COMPLETED THE PATIENT WHO DIED, STATED THAT HE FELT LIGHT-HEADED, THEN THE PATIENT STATED THAT HE WANTED TO VOMIT, HOWEVER HE DID NOT. THE PATIENT LAY DOWN AND WENT INTO CARDIAC ARREST, THE BLOOD PRESSURE WAS NORMAL BUT THE O2 SATURATION REMAINED AT 84%. PARAMEDICS WERE CALLED AND RESUSCITATION MEASURES WERE PERFORMED, THE PATIENT REGAINED CIRCULATION AND WAS SENT TO THE MAIN HOSPITAL IN THE CITY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED THAT SHOWED THE HYDROGEL WAS IN PLACE. THE PATIENT DIED NEXT DAY, AND AUTOPSY WAS PERFORMED, THE EXAM REVEALED THAT THE PATIENT HAD CORONARY ARTERIES OCCLUDED, IT WAS ALSO NOTED THAT THIS PATIENT HAD BEEN REFERRED TO CARDIOLOGY MORE THAN ONCE, AUTOPSY ALSO SHOWED MICROSCOPIC AMOUNTS OOF HYDROGEL IN THE PROSTATIC AND PULMONARY VASCULATURE. THE AUTOPSY DID NO ENLIST ONE SPECIFIC CAUSE OF DEATH BUT RATHER LISTED CORONARY ARTERY BLOCKAGE AND PULMONARY EMBOLI OOF THE HYDROGEL UNDER CAUSE OOF DEATH SECTION. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS LIKELY MULTIFACTORIAL, AND THE PROCEDURE SOMEHOW CONTRIBUTE THE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1462606 | SPACEOAR VUE SYSTEM | ABSORBABLE PERIRECTAL SPACER | OVB | BOSTON SCIENTIFIC CORPORATION | SV-2101 | 00864661000140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death |