ULTRAFLEX

Report

Report Number: 3005099803-2011-00249
Event Type: Injury
Date Received: February 15, 2011
Date of Event: January 20, 2011
Report Date: January 21, 2011
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: ESW
PMA / PMN Number: K955347
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - NON-SURGICAL MEDICAL INTERVENTION PERFORMED. (B)(4) - THE REPORTED ISSUE OF STENT POSITIONING PROBLEM. THE DEVICE 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.

Additional Manufacturer Narrative · 1

A VISUAL EXAMINATION REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED TOGETHER WITH TWO STENTS. BOTH STENTS WERE RETURNED POSITIONED ON THE DISTAL END OF THE STENT DELIVERY SYSTEM. THE STENT POSITIONED NEAREST TO THE GUIDEWIRE ACCESS PORT WAS FULLY DEPLOYED (SUBJECT STENT) AND OVERLAPPED THE PROXIMAL EDGE OF THE SECOND PARTIALLY DEPLOYED STENT. THIS STENT WAS PARTIALLY DEPLOYED BY 8CM. THE PRESENCE OF TWO STENTS ON THE DELIVERY SYSTEM WAS AS A DIRECT RESULT OF THE PHYSICIAN'S ATTEMPTS TO REMOVE ONE OF THE STENTS AND ENDING UP RETRACTING BOTH. VISUAL EXAMINATION OF THE STENT DELIVERY SYSTEM NOTED THAT THE SHAFT HAD BEEN CUT APPROXIMATELY 92.5 CM FROM THE TIP OF THE DEVICE, AS PER THE COMPLAINT DESCRIPTION. THE DEPLOYMENT SUTURE HAD ALSO BEEN SEVERED AND THE YELLOW PULL RING TOGETHER WITH THE REMAINDER OF THE SUTURE THREAD WERE NOT RECEIVED WITH THE RETURNED UNIT. ONCE THE THREAD WAS RELEASED FROM THE STRUTS THE REMAINDER OF THE DEVICE DEPLOYED WITH NO ISSUES NOTED. NO FURTHER ISSUES WERE NOTED WITH THE RETURNED UNIT. BASED ON THE EVALUATION CONDUCTED, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. 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.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX ESOPHAGEAL COVERED STENTS WERE USED DURING AN ESOPHAGEAL STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS PERFORMED IN ORDER TO DILATE THE ESOPHAGUS DUE TO ESOPHAGEAL ATRESIA AND TO CLOSE A TRACHEOESOPHAGEAL FISTULA. IT IS UNKNOWN IF THE FISTULA WAS ASSOCIATED WITH A MALIGNANCY. THE FIRST ESOPHAGEAL STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2011-00249) WAS SUCCESSFULLY DEPLOYED ON THE TRACHEOBRONCHIAL FISTULA. CONTRAST DYE WAS INJECTED; HOWEVER IT SHOWED BRONCHI. AS A RESULT OF THE BRONCHI BEING PRESENT, THE PHYSICIAN SUSPECTED THAT THE FISTULA HAD NOT BEEN PROPERLY CLOSED. A SECOND ESOPHAGEAL STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2011-00247) WAS ATTEMPTED TO BE DEPLOYED IN THE UPPER END OF THE FIRST ESOPHAGEAL STENT. DURING DEPLOYMENT OF THE SECOND STENT, THE DEPLOYMENT SUTURE BECAME TANGLED, AND THE STENT WAS ONLY PARTIALLY DEPLOYED. THE PHYSICIAN CUT THE HANDLE OF THE STENT AND USED AN OVERTUBE IN ORDER TO REMOVE THE PARTIALLY DEPLOYED STENT. DURING THIS ACTION BOTH STENTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE USER DID NOT INTENDED TO REMOVE BOTH STENTS; HOWEVER THERE WERE NO COMPLICATIONS OR ISSUES DURING THE REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX ESOPHAGEAL COVERED STENTS WERE USED DURING AN ESOPHAGEAL STENTING PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS PERFORMED IN ORDER TO DILATE THE ESOPHAGUS DUE TO ESOPHAGEAL ATRESIA AND TO CLOSE A TRACHEOESOPHAGEAL FISTULA. IT IS UNKNOWN IF THE FISTULA WAS ASSOCIATED WITH A MALIGNANCY. THE FIRST ESOPHAGEAL STENT WAS SUCCESSFULLY DEPLOYED ON THE TRACHEOBRONCHIAL FISTULA. CONTRAST DYE WAS INJECTED; HOWEVER, IT SHOWED BRONCHI. AS A RESULT OF THE BRONCHI BEING PRESENT, THE PHYSICIAN SUSPECTED THAT THE FISTULA HAD NOT BEEN PROPERLY CLOSED. A SECOND ESOPHAGEAL STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2011-00247) WAS ATTEMPTED TO BE DEPLOYED IN THE UPPER END OF THE FIRST ESOPHAGEAL STENT. DURING DEPLOYMENT OF THE SECOND STENT, THE DEPLOYMENT SUTURE BECAME TANGLED, AND THE STENT WAS ONLY PARTIALLY DEPLOYED. THE PHYSICIAN CUT THE HANDLE OF THE STENT AND USED AN OVERTUBE IN ORDER TO REMOVE THE PARTIALLY DEPLOYED STENT. DURING THIS ACTION BOTH STENTS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE USER DID NOT INTENDED TO REMOVE BOTH STENTS; HOWEVER, THERE WERE NO COMPLICATIONS OR ISSUES DURING THE REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ULTRAFLEX	PROSTHESIS, ESOPHAGEAL	ESW	BOSTON SCIENTIFIC - GALWAY	M00513100	0013249912

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	OVERTUBE