PROPEL MINI® (MOMETASONE FUROATE SINUS IMPLANT)
Report
- Report Number
- 3008301917-2024-00002
- Event Type
- Injury
- Date Received
- August 30, 2024
- Date of Event
- March 10, 2024
- Report Date
- July 11, 2025
- Manufacturer
- INTERSECT ENT INC.
- Product Code
- OWO
- UDI-DI
- 00763000840143
- PMA / PMN Number
- P100044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED FROM THE CLINICAL SITE WHICH UPDATED THE AE TERM FROM INFECTION TO SINUS INFECTION FOR APPROPRIATE MEDICAL CODING. NO ADDITIONAL UPDATES WERE MADE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO POST FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) COMPLICATIONS LEADING TO D ELAYED WOUND HEALING AND INFECTION. AS THE EVENT WAS REPORTABLE TO A REGULATORY AUTHORITY, AN INVESTIGATION WAS REQUIRED. DEVICE RETURN WAS NOT REQUESTED AS THE IMPLANT ON THE LEFT SIDE WAS DISCARDED UPON REMOVAL AND ITS UNKNOWN IF THE IMPLANT ON THE RIGHT SIDE WAS STILL IN USE OR IF IT WAS DISCARDED. THEREFORE, DEVICE ANALYSIS WAS NOT PERFORMED. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POTENTIAL MANUFACTURING ISSUE. THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. ON 4 MARCH 2024 FESS WAS PERFORMED ON PATIENT AND ON THE SAME DAY PROPEL MINI IMPLANT WAS IMPLANTED BILATERALLY IN THE ETHMOID SINUS. ON 10 MARCH 2024 PATIENT WAS HOSPITALIZED WITH HEADACHE, PRESSURE PAIN IN THE FACE AND SWOLLEN EYELID ON THE LEFT SIDE. INTRAVENOUS ANTIBIOTICS (IV) THERAPY WAS STARTED WITH IMPROVING RESULTS. ON 13 MARCH 2024 PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON 25 MARCH 2024 PATIENT CAME TO THE OUTPATIENT DEPARTMENT WITH STILL EXISTING PRESSURE PAIN ON THE LEFT SIDE OF THE FACE. THE LEFT ETHMOID PROPEL MINI IMPLANT WAS PARTIALLY REMOVED AND WAS DISCARDED IN THE HOSPITAL WASTE IN THE OUTPATIENT DEPARTMENT. ON 19 APRIL 2024 PATIENT BROUGHT THE CT SCAN OF THE MIDDLE FACE WHICH SHOWS INFECTION RELATED SWELLING TO THE OUTPATIENT DEPARTMENT. PATIENT WAS RECOMMENDED TO CONTINUE ANTIBIOTIC THERAPY. MED SAFETY ASSESSMENT CONCLUDED THAT THE POST-FESS COMPLICATIONS LEAD TO THE INFECTION, WHICH MANIFESTED AS HEADACHE, PRESSURE/PAIN IN FACE ON LEFT SIDE, SWOLLEN EYELID ON LEFT SIDE. WHILE IT IS POSSIBLE THAT THIS EVENT COULD BE RELATED TO MDT PRODUCT, IT IS A REMOTE POSSIBILITY AND IT IS MORE LIKELY TO BE RELATED TO POST-FESS COMPLICATIONS DUE TO ADVANCED DISEASE STATE, THE INHERENT RISK OF INFECTION, AND EXACERBATED BY PATIENT BEING CURRENT SMOKER. IT IS MORE LIKELY TO BE ATTRIBUTED TO INHERENT RISK INVOLVED IN AN EXTENSIVE SINUS SURGERY. THE CUSTOMER WAS CONTACTED SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT, BUT NO RESPONSE WAS RECEIVED. NO ADDITIONAL INFORMATION IS AVAILABLE ABOUT THE PATIENT SINCE HE WITHDREW HIS INFORMED CONSENT FOR FURTHER PARTICIPATION IN THE STUDY. THE COMPLAINT INVESTIGATION DETERMINED THAT THE EVENT IS INCLUDED IN RISK DOCUMENTS. THE COMPLAINT INVESTIGATION DETERMINED THAT THERE WAS INSUFFICIENT INFORMATION TO INITIATE FURTHER ACTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, THE INVESTIGATION WILL BE RE-OPENED AND UPDATED ACCORDINGLY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
BASED ON THE MEDICAL SAFETY REVIEW: THIS PATIENT IS PART OF A MEDTRONIC PRODUCT SURVEILLANCE REGISTRY, DOCUMENTED IN DATABASE: MEDIDATA RAVE EDC MDT22005PSRENT. MEDICATIONS PER DATABASE: AMPICILLIN/SULBACTAM: 2000/1000 MILLIGRAM 3 TIMES PER DAY INTRAVENOUS WOUND HEALING PROBLEM (B)(6) 2024 IMPROVING SYMPTOMS AMOCLAV 875/125 MILLIGRAM 3 TIMES PER DAY ORAL WOUND HEALING PROBLEMS (B)(6) 2024 NO IMPROVEMENT PROPEL MINI WAS IMPLANTED ON (B)(6) 2024, BILATERALLY TO ETHMOID SINUSES. DATE THE AE STARTED IS (B)(6) 2024 PER DATABASE AND DATE OF INITIAL AE DATA ENTRY IS (B)(6) 2024. AE TERM IS WOUND HEALING PROBLEM, AND SEVERITY OF THE AE IS REPORTED AS SEVERE. PER DATABASE, AE RELATED TO ETHMOID IMPLANT PROCEDURE IS NOTED AS POSSIBLE, AE RELATED TO STUDY DEVICE AND IMPLANT STUDY DRUG IS NOTED AS POSSIBLE, AE RELATED TO THE DISEASE UNDER STUDY IS NOTED POSSIBLE. PER THE DATABASE, THIS PATIENT UNDERWENT EXTENSIVE SINUS SURGERY INCLUDING BILATERAL FRONTAL SINUSOTOMY, BILATERAL ANTERIOR AND POSTERIOR ETHMOIDECTOMY, BILATERAL MAXILLARY ANTROSTOMY, BILATERAL UNCINECTOMY AND BILATERAL SPHENOIDECTOMY INDICATING AN ADVANCED CRS DISEASE STATE AND INCREASED LIKELIHOOD OF POST FESS COMPLICATIONS. WOUNDS THAT EXHIBIT IMPAIRED HEALING, INCLUDING DELAYED ACUTE WOUNDS AND CHRONIC WOUNDS, GENERALLY HAVE FAILED TO PROGRESS THROUGH THE NORMAL STAGES OF HEALING. SUCH WOUNDS FREQUENTLY ENTER A STATE OF PATHOLOGIC INFLAMMATION DUE TO A POSTPONED, INCOMPLETE, OR UNCOORDINATED HEALING PROCESS, AND OFTEN LEAD TO INFECTIONS. SYSTEMIC FACTORS SUCH AS SMOKING (THIS PATIENT IS CURRENT SMOKER PER DATABASE) ARE KNOWN TO AFFECT WOUND HEALING PROCESS. THE EXTENT OF INFECTION THAT REQUIRED INTRAVENOUS ANTIBIOTICS FOLLOWED BY ORAL ANTIBIOTICS FOR THIS PATIENT, IS NOT KNOWN AT THIS TIME NOR IS IT KNOWN IF PROPEL WAS PARTIALLY EXPLANTED BILATERALLY. WHILE LOCALIZED INFECTION IN NOSE OR PHARYNX IS LISTED AS POTENTIAL AE IN PROPEL MINI IFU (00341 REV T), A LOCALIZED INFECTION WOULD ORDINARILY NOT WARRANT INTRAVENOUS ANTIBIOTICS FOR SEVERAL DAYS FOLLOWED BY COURSE OF ORAL ANTIBIOTIC. WHILE IT IS POSSIBLE THAT THIS EVENT COULD BE RELATED TO MDT PRODUCT, IT IS A REMOTE POSSIBILITY AND IT IS MORE LIKELY TO BE RELATED TO POST-FESS COMPLICATIONS DUE TO ADVANCED DISEASE STATE EXACERBATED BY PATIENT BEING CURRENT SMOKER. RISK FILE REVIEW: EVENTS OF ALTERED WOUND HEALING AND INFECTION ARE IN RISK DOCUMENTS (R-35660 REV Q, PROPEL MINI DFMEA) AND SEVERITY IS NOT EXCEEDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B3 HAS BEEN UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PROBLEM WITH WOUND HEALING AFTER THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY AND THE SYMPTOMS IMPROVED SLIGHTLY. HE CAME TO A FOLLOW UP WITH SUSPECTED RECURRENCE OF CRS. ADDITIONAL FOLLOW UP INFO UPDATED THE AE TERM TO INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO WOUND HEALING PROBLEMS 6 DAYS AFTER FESS. HE HAS HEADACHE, PRESSURE PAIN IN THE FACE AND SWOLLEN EYELID LEFT SIDE. ADDITIONAL FOLLOW UP INFO UPDATED THE AE TERM TO SINUS INFECTION.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PROBLEM WITH WOUND HEALING AFTER THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY AND THE SYMPTOMS IMPROVED SLIGHTLY. HE CAME TO A FOLLOW UP WITH SUSPECTED RECURRENCE OF CRS. ADDITIONAL FOLLOW UP INFO UPDATED THE AE TERM TO INFECTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO WOUND HEALING PROBLEMS 6 DAYS AFTER FESS. HE HAS HEADACHE, PRESSURE PAIN IN THE FACE AND SWOLLEN EYELID LEFT SIDE.
IT WAS REPORTED THAT THE WAS ADMITTED TO THE HOSPITAL DUE TO PROBLEM WITH WOUND HEALING AFTER THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY AND THE SYMPTOMS IMPROVED SLIGHTLY. HE CAME TO A FOLLOW UP WITH SUSPECTED RECURRENCE OF CRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1802233 | PROPEL MINI® (MOMETASONE FUROATE SINUS IMPLANT) | DRUG-ELUTING SINUS STENT | OWO | INTERSECT ENT INC. | 60011 | 23071709 | 00763000840143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Male | Required Intervention| H |