ULTRAFLEX¿ TRACHEOBRONCHIAL

Report

Report Number: 3005099803-2013-00052
Event Type: Injury
Date Received: January 9, 2013
Date of Event: December 18, 2012
Report Date: December 18, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: JCT
PMA / PMN Number: K012883
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN DEPLOYED FROM THE DEVICE AND HAD NOT BEEN RETURNED. NO ISSUES WERE NOTED WITH THE SHAFT OF THE DEVICE. IT WAS NOTED THAT THE DISTAL SILASTIC TUBING HAD DETACHED FROM THE DEVICE AND HAD NOT BEEN RETURNED. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED, WHICH CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED; THEREFORE, THE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE. THE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THE REPORTED EVENT.

Additional Manufacturer Narrative · 1

PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD (B)(4) THE REPORTED ISSUE OF STENT EXPANSION ISSUES. (B)(4) THE REPORTED ISSUE OF STENT POSITIONING/PLACEMENT ISSUE. (B)(4) THE REPORTED EVENT OF CATHETER DIFFICULT TO REMOVE/WITHDRAW. THE COMPLAINT INDICATED THAT THE STENT HAS BEEN IMPLANTED; HOWEVER THE DELIVERY SYSTEM HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED DURING A LUNG STENTING PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE PROCEDURE WAS DILATION OF A BRONCHIAL STENOSIS DUE TO LUNG CANCER. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE DEVICE INTO TARGET SITE OVER THE JAGWIRE. THERE WERE NO ISSUES DURING INSERTION OR PREPARATION OF THE DEVICE. THE STENT WAS ABLE TO BE RELEASED; HOWEVER, IT WAS REPORTED THAT AT THE END IT FELT LIKE IT WAS CAUGHT IN SOMETHING. THE PHYSICIAN CHECKED THE STENT UNDER FLUOROSCOPIC GUIDANCE AND NOTICED THAT THE DISTAL END OF THE STENT WAS NOT FULLY OPEN. AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM SLOWLY, BUT IT WAS STOPPED AS THE DISTAL TIP OF THE DELIVERY SYSTEM WAS CAUGHT IN THE DISTAL SIDE OF THE STENT. AFTER WAITING APPROXIMATELY 10 MINUTES THE STENT STILL DID NOT EXPAND; BUT, THE PHYSICIAN DECIDED TO WITHDRAW THE DELIVERY SYSTEM AGAIN. DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT WAS MOVED OUT OF POSITION, TOWARDS THE PROXIMAL SIDE. USING FORCEPS, THE STENT WAS REPOSITIONED TOWARDS THE DISTAL SIDE AND LEFT IMPLANTED. SUBSEQUENTLY, THE POSITIONING OF THE STENT WAS NOT AT THE TARGET SITE; THEREFORE, A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED IN THE OPPOSITE BRONCHUS. AS A RESULT, IT WAS REPORTED THAT "IMPROVEMENT OF BREATHING FUNCTION OF THE PATIENT IS FAVORABLE". THE COMPLAINT STENT WAS EXAMINED OVER 1 HOUR AFTER PLACEMENT AND IT STILL HAD NOT FULLY EXPANDED AT THE DISTAL END. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED DURING A LUNG STENTING PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE PROCEDURE WAS DILATION OF A BRONCHIAL STENOSIS DUE TO LUNG CANCER. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE DEVICE INTO TARGET SITE OVER THE JAGWIRE. THERE WERE NO ISSUES DURING INSERTION OR PREPARATION OF THE DEVICE. THE STENT WAS ABLE TO BE RELEASED; HOWEVER, IT WAS REPORTED THAT AT THE END IT FELT LIKE IT WAS CAUGHT IN SOMETHING. THE PHYSICIAN CHECKED THE STENT UNDER FLUOROSCOPIC GUIDANCE AND NOTICED THAT THE DISTAL END OF THE STENT WAS NOT FULLY OPEN. AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM SLOWLY, BUT IT WAS STOPPED AS THE DISTAL TIP OF THE DELIVERY SYSTEM WAS CAUGHT IN THE DISTAL SIDE OF THE STENT. AFTER WAITING APPROXIMATELY 10 MINUTES THE STENT STILL DID NOT EXPAND; BUT, THE PHYSICIAN DECIDED TO WITHDRAW THE DELIVERY SYSTEM AGAIN. DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT WAS MOVED OUT OF POSITION, TOWARDS THE PROXIMAL SIDE. USING FORCEPS, THE STENT WAS REPOSITIONED TOWARDS THE DISTAL SIDE AND LEFT IMPLANTED. SUBSEQUENTLY, THE POSITIONING OF THE STENT WAS NOT AT THE TARGET SITE; THEREFORE, A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED IN THE OPPOSITE BRONCHUS. AS A RESULT, IT WAS REPORTED THAT 'IMPROVEMENT OF BREATHING FUNCTION OF THE PATIENT IS FAVORABLE.' THE COMPLAINT STENT WAS EXAMINED OVER 1 HOUR AFTER PLACEMENT AND IT STILL HAD NOT FULLY EXPANDED AT THE DISTAL END. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013: IT WAS REPORTED THAT THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. ADDITIONALLY, THERE WAS NO VISIBLE DAMAGE NOTED TO THE DEVICE.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED DURING A LUNG STENTING PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE PROCEDURE WAS DILATION OF A BRONCHIAL STENOSIS DUE TO LUNG CANCER. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE DEVICE INTO TARGET SITE OVER THE JAGWIRE. THERE WERE NO ISSUES DURING INSERTION OR PREPARATION OF THE DEVICE. THE STENT WAS ABLE TO BE RELEASED; HOWEVER, IT WAS REPORTED THAT AT THE END IT FELT LIKE IT WAS CAUGHT IN SOMETHING. THE PHYSICIAN CHECKED THE STENT UNDER FLUOROSCOPIC GUIDANCE AND NOTICED THAT THE DISTAL END OF THE STENT WAS NOT FULLY OPEN. AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM SLOWLY, BUT IT WAS STOPPED AS THE DISTAL TIP OF THE DELIVERY SYSTEM WAS CAUGHT IN THE DISTAL SIDE OF THE STENT. AFTER WAITING APPROXIMATELY 10 MINUTES THE STENT STILL DID NOT EXPAND; BUT, THE PHYSICIAN DECIDED TO WITHDRAW THE DELIVERY SYSTEM AGAIN. DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT WAS MOVED OUT OF POSITION, TOWARDS THE PROXIMAL SIDE. USING FORCEPS, THE STENT WAS REPOSITIONED TOWARDS THE DISTAL SIDE AND LEFT IMPLANTED. SUBSEQUENTLY, THE POSITIONING OF THE STENT WAS NOT AT THE TARGET SITE; THEREFORE, A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT WAS IMPLANTED IN THE OPPOSITE BRONCHUS. AS A RESULT, IT WAS REPORTED THAT "IMPROVEMENT OF BREATHING FUNCTION OF THE PATIENT IS FAVORABLE". THE COMPLAINT STENT WAS EXAMINED OVER 1 HOUR AFTER PLACEMENT AND IT STILL HAD NOT FULLY EXPANDED AT THE DISTAL END. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013: IT WAS REPORTED THAT THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. ADDITIONALLY, THERE WAS NO VISIBLE DAMAGE NOTED TO THE DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
10609	ULTRAFLEX¿ TRACHEOBRONCHIAL	PROSTHESIS, TRACHEAL, EXPANDABLE	JCT	BOSTON SCIENTIFIC - GALWAY	M00568970	13233284

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Required Intervention