ALAIR?
Report
- Report Number
- 3005099803-2014-02610
- Event Type
- Death
- Date Received
- July 31, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 4, 2014
- Manufacturer
- BOSTON SCIENTIFIC - CORK
- Product Code
- OOY
- PMA / PMN Number
- P080032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014. THIS PATIENT WAS A (B)(6) LIFE-LONG NON-SMOKER WITH A HISTORY OF COPD, HYPERTENSION, AND END-STAGE RENAL DISEASE, REQUIRING DIALYSIS OVER THE LAST 6-7 YEARS. THE ETIOLOGY OF THE RENAL FAILURE WAS NOT KNOWN. SHE WAS HOSPITALIZED FOR PROFOUND NEUROLOGICAL WEAKNESS APPROXIMATELY 4 YEARS AGO AND WAS UNABLE TO WALK AT THAT TIME. THE ETIOLOGY OF THE WEAKNESS WAS NEVER DETERMINED AND SHE MADE A FULL RECOVERY. IN THE YEAR PRIOR TO THE PROCEDURE, SHE HAD APPROXIMATELY 4 ASTHMA EXACERBATIONS REQUIRING ORAL CORTICOSTEROIDS, AND WAS UNABLE TO BE WEANED COMPLETELY OFF ORAL CORTICOSTEROIDS UNTIL APPROXIMATELY 4 WEEKS PRIOR TO HER PROCEDURE. SHE WAS NOT HOSPITALIZED FOR ASTHMA IN THE LAST YEAR BUT WAS TREATED EMPIRICALLY WITH AZITHROMYCIN FOR PNEUMONIA 2 MONTHS PRIOR TO THE BT TREATMENT. SHE WAS ON ALBUTEROL BY NEBULIZATION THREE TIMES PER DAY ON A CHRONIC BASIS AND THERE WAS NO CHANGE IN HER PRN USE OF MEDICATIONS IN THE PERIOD IMMEDIATELY PRECEDING THE BT PROCEDURE. HER BASELINE FEV1 WAS 0.53 LITERS OR 40% OF PREDICTED AND ON THE DAY OF THE PROCEDURE, IT WAS 0.47 LITERS OR 32% OF PREDICTED. THE PHYSICIAN FELT THE PATIENT WAS IN OPTIMAL CONDITION PRIOR TO UNDERGOING BRONCHIAL THERMOPLASTY. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE ON (B)(6) 2014. PERI-PROCEDURE ORAL CORTICOSTEROIDS WERE ADMINISTERED AS APPROPRIATE AND RECOMMENDED. THE PROCEDURE WAS PERFORMED UNDER MODERATE SEDATION AND WAS REPORTED TO BE UNEVENTFUL. THERE WERE NO REPORTED DEVICE MALFUNCTIONS. POST PROCEDURE, THE PATIENT WAS HYPOXIC AND HER FEV1 % PREDICTED WAS IN THE LOW 30% RANGE. A CHEST X-RAY REVEALED NO INFILTRATES. SHE WAS ADMINISTERED IV SOLUMEDROL AND REMAINED IN THE HOSPITAL OVERNIGHT. THE NEXT MORNING HER FEV1 % PREDICTED WAS IN THE MID-30% RANGE AND SHE WAS KEPT IN THE HOSPITAL AN ADDITIONAL NIGHT. SHE UNDERWENT HER USUAL KIDNEY DIALYSIS TREATMENT AT THIS TIME. BOTH HER CHEST X-RAY AND SPUTUM CULTURE WERE NORMAL. SHE WAS DISCHARGED ON (B)(6) 2014 WITH HOME OXYGEN AND A FEV1 % PREDICTED IN THE LOW 40% RANGE, CLOSE TO HER USUAL VALUE OF APPROXIMATELY MID-40%. ON (B)(6) 2014, A SCHEDULED FOLLOW UP CALL WAS CONDUCTED. THE PATIENT WAS REPORTED TO BE FINE AND CLOSELY MONITORED BY HER FAMILY AT HOME. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT HAD A PERSISTENT COUGH AND INCREASED SHORTNESS OF BREATH. AZITHROMYCIN WAS PRESCRIBED FOR THIS. ON (B)(6) 2014, THE PATIENT WENT TO THE ER FOR INCREASED SHORTNESS OF BREATH. SHE REQUIRED HIGH DOSE OXYGEN AND WAS ADMITTED TO THE ICU. A CHEST X-RAY SHOWED RIGHT LOWER LOBAR PNEUMONIA AND A CT SCAN SHOWED MUCOUS PLUGGING AND VOLUME LOSS IN THE RIGHT LOWER LOBE. SPUTUM CULTURES GREW KLEBSIELLA AND ENTEROBACTER. SHE DEVELOPED RESPIRATORY FAILURE, WAS INTUBATED, BECAME HYPOTENSIVE, AND WENT INTO SEPTIC SHOCK. AT ALL TIMES IN HOSPITAL, SHE WAS ON BROAD SPECTRUM ANTIBIOTICS AND CORTICOSTEROIDS. SHE EXPIRED ON THE MORNING OF (B)(6) 2014. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS DETERMINED TO BE KLEBSIELLA AND ENTEROBACTER PNEUMONIA WITH SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) AND SEPTIC SHOCK. THE PHYSICIAN INDICATED THAT THE BT PROCEDURE AND THE DIALYSIS TREATMENT MAY HAVE BEEN RELATED TO OR CONTRIBUTED TO THE PATIENT¿S DEATH. IT WAS REPORTED THAT AN AUTOPSY WILL NOT BE PERFORMED. ACCORDING TO PRECAUTIONS OUTLINED IN THE ALAIR CATHETER DIRECTIONS FOR USE (DFU), CAUTION SHOULD BE TAKEN IN PATIENTS WITH THE FOLLOWING CONDITIONS DUE TO A POTENTIAL INCREASED RISK OF ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE PROCEDURE: POST-BRONCHODILATOR FEV1 < 65%, OTHER RESPIRATORY DISEASES, ACUTE OR CHRONIC RENAL FAILURE OR 4 OR MORE OCS (ORAL CORTICOSTEROID) PULSES FOR ASTHMA EXACERBATIONS WITHIN THE PAST 12 MONTHS. THE DFU STATES THAT PATIENTS WITH THESE CONDITIONS WERE NOT STUDIED IN THE PIVOTAL TRIAL AND SAFETY OF ALAIR TREATMENT FOR SUCH PATIENTS HAS NOT BEEN DETERMINED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT WILL BE SUBMITTED IN A SUPPLEMENTAL MDR.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014. THIS PATIENT WAS A (B)(6) LIFE-LONG NON-SMOKER WITH A HISTORY OF COPD, HYPERTENSION, AND END-STAGE RENAL DISEASE, REQUIRING DIALYSIS OVER THE LAST 6-7 YEARS. THE ETIOLOGY OF THE RENAL FAILURE WAS NOT KNOWN. SHE WAS HOSPITALIZED FOR PROFOUND NEUROLOGICAL WEAKNESS APPROXIMATELY 4 YEARS AGO AND WAS UNABLE TO WALK AT THAT TIME. THE ETIOLOGY OF THE WEAKNESS WAS NEVER DETERMINED AND SHE MADE A FULL RECOVERY. IN THE YEAR PRIOR TO THE PROCEDURE, SHE HAD APPROXIMATELY 4 ASTHMA EXACERBATIONS REQUIRING ORAL CORTICOSTEROIDS, AND WAS UNABLE TO BE WEANED COMPLETELY OFF ORAL CORTICOSTEROIDS UNTIL APPROXIMATELY 4 WEEKS PRIOR TO HER PROCEDURE. SHE WAS NOT HOSPITALIZED FOR ASTHMA IN THE LAST YEAR BUT WAS TREATED EMPIRICALLY WITH AZITHROMYCIN FOR PNEUMONIA 2 MONTHS PRIOR TO THE BT TREATMENT. SHE WAS ON ALBUTEROL BY NEBULIZATION THREE TIMES PER DAY ON A CHRONIC BASIS AND THERE WAS NO CHANGE IN HER PRN USE OF MEDICATIONS IN THE PERIOD IMMEDIATELY PRECEDING THE BT PROCEDURE. HER BASELINE FEV1 WAS 0.53 LITERS OR 40% OF PREDICTED AND ON THE DAY OF THE PROCEDURE, IT WAS 0.47 LITERS OR 32% OF PREDICTED. THE PHYSICIAN FELT THE PATIENT WAS IN OPTIMAL CONDITION PRIOR TO UNDERGOING BRONCHIAL THERMOPLASTY. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE ON (B)(6) 2014. PERI-PROCEDURE ORAL CORTICOSTEROIDS WERE ADMINISTERED AS APPROPRIATE AND RECOMMENDED. THE PROCEDURE WAS PERFORMED UNDER MODERATE SEDATION AND WAS REPORTED TO BE UNEVENTFUL. THERE WERE NO REPORTED DEVICE MALFUNCTIONS. POST PROCEDURE, THE PATIENT WAS HYPOXIC AND HER FEV1 % PREDICTED WAS IN THE LOW 30% RANGE. A CHEST X-RAY REVEALED NO INFILTRATES. SHE WAS ADMINISTERED IV SOLUMEDROL AND REMAINED IN THE HOSPITAL OVERNIGHT. THE NEXT MORNING HER FEV1 % PREDICTED WAS IN THE MID-30% RANGE AND SHE WAS KEPT IN THE HOSPITAL AN ADDITIONAL NIGHT. SHE UNDERWENT HER USUAL KIDNEY DIALYSIS TREATMENT AT THIS TIME. BOTH HER CHEST X-RAY AND SPUTUM CULTURE WERE NORMAL. SHE WAS DISCHARGED ON (B)(6) 2014 WITH HOME OXYGEN AND A FEV1 % PREDICTED IN THE LOW 40% RANGE, CLOSE TO HER USUAL VALUE OF APPROXIMATELY MID-40%. ON (B)(6) 2014, A SCHEDULED FOLLOW UP CALL WAS CONDUCTED. THE PATIENT WAS REPORTED TO BE FINE AND CLOSELY MONITORED BY HER FAMILY AT HOME. ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT HAD A PERSISTENT COUGH AND INCREASED SHORTNESS OF BREATH. AZITHROMYCIN WAS PRESCRIBED FOR THIS. ON (B)(6) 2014, THE PATIENT WENT TO THE ER FOR INCREASED SHORTNESS OF BREATH. SHE REQUIRED HIGH DOSE OXYGEN AND WAS ADMITTED TO THE ICU. A CHEST X-RAY SHOWED RIGHT LOWER LOBAR PNEUMONIA AND A CT SCAN SHOWED MUCOUS PLUGGING AND VOLUME LOSS IN THE RIGHT LOWER LOBE. SPUTUM CULTURES GREW KLEBSIELLA AND ENTEROBACTER. SHE DEVELOPED RESPIRATORY FAILURE, WAS INTUBATED, BECAME HYPOTENSIVE, AND WENT INTO SEPTIC SHOCK. AT ALL TIMES IN HOSPITAL, SHE WAS ON BROAD SPECTRUM ANTIBIOTICS AND CORTICOSTEROIDS. SHE EXPIRED ON (B)(6) 2014. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS DETERMINED TO BE KLEBSIELLA AND ENTEROBACTER PNEUMONIA WITH SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) AND SEPTIC SHOCK. THE PHYSICIAN INDICATED THAT THE BT PROCEDURE AND THE DIALYSIS TREATMENT MAY HAVE BEEN RELATED TO OR CONTRIBUTED TO THE PATIENT¿S DEATH. IT WAS REPORTED THAT AN AUTOPSY WILL NOT BE PERFORMED. ACCORDING TO PRECAUTIONS OUTLINED IN THE ALAIR CATHETER DIRECTIONS FOR USE (DFU), CAUTION SHOULD BE TAKEN IN PATIENTS WITH THE FOLLOWING CONDITIONS DUE TO A POTENTIAL INCREASED RISK OF ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE PROCEDURE: POST-BRONCHODILATOR FEV1 < 65%, OTHER RESPIRATORY DISEASES, ACUTE OR CHRONIC RENAL FAILURE OR 4 OR MORE OCS (ORAL CORTICOSTEROID) PULSES FOR ASTHMA EXACERBATIONS WITHIN THE PAST 12 MONTHS. THE DFU STATES THAT PATIENTS WITH THESE CONDITIONS WERE NOT STUDIED IN THE PIVOTAL TRIAL AND SAFETY OF ALAIR TREATMENT FOR SUCH PATIENTS HAS NOT BEEN DETERMINED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT WILL BE SUBMITTED IN A SUPPLEMENTAL MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446481 | ALAIR? | BRONCHIAL THERMOPLASTY SYSTEM | OOY | BOSTON SCIENTIFIC - CORK | M005ATS25010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death| H| R |