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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSECT ENT, INC. PROPEL MINI (MOMETASONE FUROATE IMPLANT, 370 G); DRUG-ELUTING STENT
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INTERSECT ENT, INC. PROPEL MINI (MOMETASONE FUROATE IMPLANT, 370 G); DRUG-ELUTING STENT Back to Search Results
Model Number 70029
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Pain (1994); Fungal Infection (2419)
Event Date 10/06/2020
Event Type  Injury  
Manufacturer Narrative
Based upon intersect ent's physician medical review assessed event as unlikely that the implant caused a fungal infection.The patient may have had unusual anatomy in the last frontal recess as he was found by the surgeon to have a residual agger nasi cell and frontal cell despite primary and revision surgery by the implanting physician.The role of arista in the patient's clinical course is unknown.
 
Event Description
On (b)(6) 2020, a male patient underwent endoscopic sinus surgery and a propel mini was placed in left frontal sinus.Two weeks after ess, during a follow-up visit, patient complained of headaches and dr.Observed fungus as well as an extreme foul smell.The implanting physician referred the patient to an otolaryngologist surgeon, who operated on (b)(6) 2020.The surgeon notified the implanting physician of his findings that the "fungus was not invasive and that the propel mini possibly caused pressure necrosis." the implant was explanted on (b)(6) 2020.The information below was obtained during intersect follow-up on (b)(6) 2020.On (b)(6) 2020, the implanting physician preformed revision sinus surgery on a male patient to implant propel mini devices.One device was placed in the left frontal sinus ostia and a second device was placed in the right ethmoid sinus.The surgery was performed in an operating room and no balloons were used during the surgery.On (b)(6) 2020, the patient contacted the implanting physician complaining of severe pain on the left side toward the eye and radiating into the left cheek.No other symptoms were reported, notably no visual changes, fever, headache, or discharge.The patient reported the pain was severe enough that he had trouble sleeping.On (b)(6) 2020, the implanting physician saw the patient at normal follow-up in his clinic.The patient's pain had persisted, but he had developed no new symptoms.On endoscopic examination, the right side was healing as expected.On the left side (frontal ostia), the implanting physician noted fungal hyphae on the implant that had a black appearing substance on it, with a very foul odor, which he felt might be necrotic tissue.After consulting an otolaryngologist surgeon, the otolaryngologist agreed to see the patient the same day.The surgeon took the patient to the operating room after seeing him in clinic, to ascertain if the patient had an invasive fungal sinus infection.In the operating room, surgeon encountered residual agger nasi cell that contained pus as well as a frontal cell, both of which he opened surgically.He [?]drilled out' the frontal recess and obtained biopsies for frozen section analysis as well as permanent pathology evaluation.The initial frozen section report showed fungus [?]not concerning for invasive fungal sinusitis' and [?]dead tissue' adjacent to the lamina papyracea.The patient was kept overnight for observation and reported felt completely better and was discharged the next morning.The patient is reportedly doing well with no residual symptoms or concerns.The final pathology report from (b)(6) 2020 confirmed fungal elements and necrotic tissue.The implanting physician had spoken with the otolaryngologist surgeon who reportedly speculated that the implant may have caused pressure necrosis of the underlying tissue.
 
Manufacturer Narrative
Based upon intersect ent's physician medical review assessed event as unlikely that the implant caused a fungal infection.The patient may have had unusual anatomy in the last frontal recess as he was found by the surgeon to have a residual agger nasi cell and frontal cell despite primary and revision surgery by the implanting physician.The role of arista in the patient's clinical course is unknown.
 
Event Description
On (b)(6) 2020, a male patient underwent endoscopic sinus surgery and a propel mini was placed in left frontal sinus.Two weeks after ess, during a follow-up visit, patient complained of headaches and dr.Observed fungus as well as an extreme foul smell.The implanting physician referred the patient to an otolaryngologist surgeon, who operated on (b)(6) 2020.The surgeon notified the implanting physician of his findings that the "fungus was not invasive and that the propel mini possibly caused pressure necrosis." the implant was explanted on (b)(6) 2020.The information below was obtained during intersect follow-up on (b)(6) 2020.On (b)(6) 2020, the implanting physician preformed revision sinus surgery on a male patient to implant propel mini devices.One device was placed in the left frontal sinus ostia and a second device was placed in the right ethmoid sinus.The surgery was performed in an operating room and no balloons were used during the surgery.On (b)(6) 2020, the patient contacted the implanting physician complaining of severe pain on the left side toward the eye and radiating into the left cheek.No other symptoms were reported, notably no visual changes, fever, headache, or discharge.The patient reported the pain was severe enough that he had trouble sleeping.On (b)(6) 2020, the implanting physician saw the patient at normal follow-up in his clinic.The patient's pain had persisted, but he had developed no new symptoms.On endoscopic examination, the right side was healing as expected.On the left side (frontal ostia), the implanting physician noted fungal hyphae on the implant that had a black appearing substance on it, with a very foul odor, which he felt might be necrotic tissue.After consulting an otolaryngologist surgeon, the otolaryngologist agreed to see the patient the same day.The surgeon took the patient to the operating room after seeing him in clinic, to ascertain if the patient had an invasive fungal sinus infection.In the operating room, surgeon encountered residual agger nasi cell that contained pus as well as a frontal cell, both of which he opened surgically.He drilled out' the frontal recess and obtained biopsies for frozen section analysis as well as permanent pathology evaluation.The initial frozen section report showed fungus not concerning for invasive fungal sinusitis' and dead tissue' adjacent to the lamina papyracea.The patient was kept overnight for observation and reported felt completely better and was discharged the next morning.The patient is reportedly doing well with no residual symptoms or concerns.The final pathology report from (b)(6) 2020 confirmed fungal elements and necrotic tissue.The implanting physician had spoken with the otolaryngologist surgeon who reportedly speculated that the implant may have caused pressure necrosis of the underlying tissue.
 
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Brand Name
PROPEL MINI (MOMETASONE FUROATE IMPLANT, 370 G)
Type of Device
DRUG-ELUTING STENT
Manufacturer (Section D)
INTERSECT ENT, INC.
1555 adams dr
menlo park CA 94025 1439
MDR Report Key10841298
MDR Text Key216328928
Report Number3008301917-2020-00002
Device Sequence Number1
Product Code OWO
Combination Product (y/n)Y
PMA/PMN Number
P100044
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number70029
Device Catalogue Number60011
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATORVASTATIN; ATORVASTATIN; BABY ASPRIN; BABY ASPRIN; DICLOFENAC; DICLOFENAC; FLOMAX; FLOMAX; FLONASE; FLONASE; KEFLEX; KEFLEX; LOSARTAN; LOSARTAN
Patient Outcome(s) Hospitalization;
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