THE PATIENT'S GRANULOMATOUS REACTION IS LIKELY DUE TO A DELAYED FOREIGN BODY/ALLERGEN-MEDIATED REACTION TO A COMPONENT OR COMPONENTS OF THE SINUS IMPLANT. IT IS SUSPECT THE PATIENT HAS A PREVIOUSLY UNDIAGNOSED AUTO-IMMUNE OR HYPERSENSITIVITY DISORDER. FOREIGN BODY REACTION IS A KNOWN RISK IN PATIENTS WHO ARE SUSCEPTIBLE TO THIS TYPE OF REACTION. THE PATIENTS' WEIGHT AND THE LOT NUMBER(S) OF THE DEVICES ARE NOT KNOWN TO THE MANUFACTURER. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT RETURNED TO THE MANUFACTURER. RISKS ASSOCIATED WITH THE USE OF THIS SINUS IMPLANT ARE ANTICIPATED TO BE SIMILAR TO THOSE EXPERIENCED BY PATIENTS WHO UNDERGO PLACEMENT OF OTHER SINUS IMPLANTS OR PACKING. FOREIGN BODY REACTION MAY OCCUR AS IS POSSIBLE WITH MOST SURGICAL ADJUNCTS. THE FOLLOWING IS BEING PROVIDED AS THIS DEVICE IS A COMBINATION PRODUCT: NAME: PROPEL OR PROPEL MINI (POPULATE AS APPROPRIATE), DOSE, FREQUENCY & ROUTE USED: (1) 370 UG IMPLANT, DIAGNOSIS FOR USE: SINUS SURGERY, COMBINATION PRODUCT -YES. REFERENCE MFR 3008301917-2017-00003 FOR FIRST IMPLANT IN THE SECOND EVENT. REFERENCE MFR 3008301917-2017-00001 AND MFR 3008301917-2017-00002 FOR THE IMPLANTS IN THE INITIAL EVENT. .
D
Patient 1
ON DAY 1, THE PATIENT UNDERWENT A SINUS PROCEDURE DURING WHICH SINUS IMPLANTS WERE PLACED BILATERALLY IN THE ETHMOID SINUSES. SEPTAL SPLINTS OF UNKNOWN MANUFACTURER WERE ALSO PLACED BILATERALLY. NO SINUS IMPLANT DEVICE MALFUNCTION OR PATIENT INJURY IS NOTED TO HAVE OCCURRED DURING THE PATIENT'S INITIAL PROCEDURE. DAY 6, THE PATIENT WAS SEEN BY THE SURGEON FOR A ROUTINE POST-OPERATIVE VISIT, AT WHICH POINT THE SEPTAL SPLINTS WERE REMOVED, AND PER REPORT, THE IMPLANTS WERE LEFT IN PLACE. AT THAT TIME, THERE WAS MILD BLEEDING UPON REMOVAL OF THE SPLINTS, AND A SMALL AMOUNT OF INFLAMMATORY TISSUE WAS PRESENT, BOTH WERE WITHIN NORMAL EXPECTATIONS. TWO DAYS LATER, PATIENT PRESENTED WITH EPISTAXIS AND WAS TAKEN BACK TO THE OR. DURING THAT PROCEDURE IT WAS NOTED THAT THE PATIENT HAD "EXTENSIVE GRANULATION TISSUE," A "LARGE BLOOD CLOT," AND A POSTERIOR BLEED. THE SURGEON ELECTED TO REMOVE THE SINUS IMPLANTS AND THEY WERE REPLACED BILATERALLY WITH NEW ONES. THE FOLLOWING NIGHT THE PATIENT REPORTED HAVING A "BIG BLEED" AND WAS SEEN BY THE SURGEON IN HER OFFICE THE NEXT DAY. THE PATIENT WAS EXAMINED ENDOSCOPICALLY AND OBSERVED THAT THE SOURCE OF THE PATIENT'S BLEED (THE PRIOR NIGHT) WAS NEAR THE SPHENOID, "EXTENSIVE GRANULATION TISSUE AROUND THE STENTS BILATERALLY AND FIBRINOUS MIDDLE TURBINATES ADHERED TO THE LATERAL WALLS." THE PHYSICIAN REMOVED THE BILATERAL IMPLANTS AND DEBRIDED THE FIBRINOUS TISSUE ENCOMPASSING THE IMPLANTS TO REMOVE THE OBSTRUCTION OF THE ETHMOID CAVITY. PATIENTS' EVENT IS COMPLETELY RESOLVED.
N
Patient 1
CORRECTED DATA: EVENT DESCRIPTION: CORRECTED SINUS PROCEDURE TO SURGICAL SINUS PROCEDURE, CORRECTED DAY 6 TO DAY 8, CORRECTED THE DAY THE PATIENT REPORTED A "BIG BLEED" FROM THE FOLLOWING NIGHT TO TWO DAYS LATER. MANUFACTURER NARRATIVE: THE PHYSICIAN CONFIRMED THERE WAS NO CAUSAL RELATIONSHIP OF EPISTAXIS WITH THE SINUS IMPLANTS.
D
Patient 1
ON DAY 1 THE PATIENT UNDERWENT A SURGICAL SINUS PROCEDURE DURING WHICH SINUS IMPLANTS WERE PLACED BILATERALLY IN THE ETHMOID SINUSES. SEPTAL SPLINTS OF UNKNOWN MANUFACTURER WERE ALSO PLACED BILATERALLY. NO SINUS IMPLANT DEVICE MALFUNCTION OR PATIENT INJURY IS NOTED TO HAVE OCCURRED DURING THE PATIENT'S INITIAL PROCEDURE. DAY 8, THE PATIENT WAS SEEN BY THE SURGEON FOR A ROUTINE POST-OPERATIVE VISIT, AT WHICH POINT THE SEPTAL SPLINTS WERE REMOVED, AND PER REPORT, THE IMPLANTS WERE LEFT IN PLACE. AT THAT TIME, THERE WAS MILD BLEEDING UPON REMOVAL OF THE SPLINTS, AND A SMALL AMOUNT OF INFLAMMATORY TISSUE WAS PRESENT, BOTH WERE WITHIN NORMAL EXPECTATIONS. TWO DAYS LATER, PATIENT PRESENTED WITH EPISTAXIS AND WAS TAKEN BACK TO THE OR. DURING THAT PROCEDURE IT WAS NOTED THAT THE PATIENT HAD "EXTENSIVE GRANULATION TISSUE," A "LARGE BLOOD CLOT," AND A POSTERIOR BLEED. THE SURGEON ELECTED TO REMOVE THE SINUS IMPLANTS AND THEY WERE REPLACED BILATERALLY WITH NEW ONES. TWO DAYS LATER, THE PATIENT REPORTED HAVING A "BIG BLEED" AND WAS SEEN BY THE SURGEON IN HER OFFICE THE NEXT DAY. THE PATIENT WAS EXAMINED ENDOSCOPICALLY AND OBSERVED THAT THE SOURCE OF THE PATIENT'S BLEED (THE PRIOR NIGHT) WAS NEAR THE SPHENOID, "EXTENSIVE GRANULATION TISSUE AROUND THE STENTS BILATERALLY AND FIBRINOUS MIDDLE TURBINATES ADHERED TO THE LATERAL WALLS." THE PHYSICIAN REMOVED THE BILATERAL IMPLANTS AND DEBRIDED THE FIBRINOUS TISSUE ENCOMPASSING THE IMPLANTS TO REMOVE THE OBSTRUCTION OF THE ETHMOID CAVITY. PATIENTS' EVENT IS COMPLETELY RESOLVED.