MAUDE MDR 1400114

MDR report key
1400114
Report number
3005099803-2009-02731
Event key
0
Event type
3
Date received
2009-06-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHARLES MONTGOMERY
Address
100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POLYFLEX AIRWAY STENTBOSTON SCIENTIFIC CORPORATIONNYTM005701607016UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-06-0501. R

Event Narratives#

D

Patient 1

NOTE: DATE OF EVENT IS UNKNOWN. ON 05/07/2009, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF AN ARTICLE, "MEDIASTINAL MIGRATION OF SELF-EXPANDING BRONCHIAL STENTS IN THE MANAGEMENT OF MALIGNANT BRONCHOESOPHAGEAL FISTULA" S. ALAZEMI MC ET AL. CHEST 2009; 135; 1353-1355, DOI 10.1378/CHEST, 2006. A FEMALE WITH STAGE IV ADENOCARCINOMA OF THE BREAST WAS EXPERIENCING INCREASING DYSPNEA AND A COUGH WHICH WAS AGGRAVATED BY EATING AND DRINKING. THE PATIENT UNDERWENT A CT SCAN OF THE CHEST WHICH SHOWED EVIDENCE OF EXTENSIVE MEDIASTINAL TUMOR INVASION WITH A FISTULA BETWEEN THE MID-PORTION OF THE ESOPHAGUS AND THE PROXIMAL LEFT MAIN BRONCHUS. SHE UNDERWENT STENT PLACEMENT OF A COVERED POLYFLEX AIRWAY STENT. TWO WEEKS POST STENT PLACEMENT, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A WORSENING COUGH. SHORTLY AFTERWARD, SHE PRESENTED WITH CHEST PAIN, WORSENING COUGH AND BREATHLESSNESS. AN ESOPHAGOSCOPY WAS PERFORMED, AND ANOTHER POLYFLEX AIRWAY STENT WAS PLACED IN AN ATTEMPT TO SEAT THE RESIDUAL FISTULA. IN ADDITION, A PERCUTANEOUS GASTROSTOMY TUBE WAS PLACED FOR NUTRITIONAL SUPPORT AND PREVENTION OF FURTHER ASPIRATION. DESPITE TREATMENT THE PATIENT CONTINUED TO HAVE A COUGH THAT BECAME PERSISTENT AND ASSOCIATED WITH CHEST PAIN. A CT SCAN OF THE CHEST REVEALED THE POLYFLEX AIRWAY STENT PROTRUDING THROUGH THE MEDIAL WALL OF THE RIGHT MAIN BRONCHUS (RMB) COMPLETELY OBSTRUCTING THE BRONCHUS INTERMEDIUS (BI). THE AIRWAY STENT WAS REMOVED EASILY USING RIGID FORCEPS. AT THIS POINT, THE CARINAL ANATOMY WAS SEVERELY DISTORTED, WITH A BILATERAL BRONCHIAL WALL PERFORATION AND A FLOPPY MIDDLE PORTION. AN ATTEMPT WAS THEREFORE MADE TO RECONSTRUCT THE CARINA ENDOSCOPICALLY WITH VARIOUS AIRWAY PROSTHESES. THE PROCEDURE WAS TOLERATED WELL BY THE PATIENT, WHO HAD SIGNIFICANT CLINICAL IMPROVEMENT OF HER DYSPNEA AND CHEST PAIN. IN ADDITION, A REPEAT CT SCAN OF THE CHEST CONFIRMED THE RESTORATION OF AIRWAY PATENCY ON THE RIGHT SIDE. SHE WAS DISCHARGED FROM THE HOSPITAL TO HOME SHORTLY AFTER COMPLETING A COURSE OF ANTIBIOTICS WITH NUTRITIONAL SUPPORT PROVIDED EXCLUSIVELY VIA THE GASTROSTOMY TUBE. AT FOLLOW-UP 2 MONTHS LATER, THE PATIENT REMAINED STABLE AT HOME WITH NO FURTHER HOSPITALIZATION.

N

Patient 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.