MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513710

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

Although the exact patient age was not provided, the patient was reported to be over 18 years of age.Reported event of stent blocked/occluded.The complainant indicated that the device remains implanted 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.

Event Description

It was reported to boston scientific corporation that an ultraflex¿ esophageal ng stent was implanted to treat a 2-3cm malignant stricture in the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2015.According to the complainant, on two occasions sometime after the esophageal stent placement procedure, it was confirmed under fluoroscopy that food had become stuck between the ultraflex¿ esophageal ng stent and the esophageal wall.When the ultraflex¿ esophageal ng stent was visualized through the scope, the inner diameter of the stent ¿looked like a crescent moon¿ as a result of the blockage.On both occasions, after the food was endoscopically removed, the ultraflex¿ esophageal ng stent returned again into its normal shape.In the physician¿s assessment, he does not believe that the condition of the stricture would have contributed to the blockage as the stricture is at the lower part of the ultraflex¿ esophageal ng stent.This device remains implanted in the patient.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal ng stent was implanted to treat a 2-3cm malignant stricture in the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2015.According to the complainant, on two occasions sometime after the esophageal stent placement procedure, it was confirmed under fluoroscopy that food had become stuck between the ultraflex esophageal ng stent and the esophageal wall.When the ultraflex esophageal ng stent was visualized through the scope, the inner diameter of the stent "looked like a crescent moon" as a result of the blockage.On both occasions, after the food was endoscopically removed, the ultraflex esophageal ng stent returned again into its normal shape.In the physician's assessment, he does not believe that the condition of the stricture would have contributed to the blockage as the stricture is at the lower part of the ultraflex esophageal ng stent.This device remains implanted in the patient.There were no patient complications reported as a result of this event.Additional information received on (b)(4) 2015: the first occlusion was noted on (b)(6) 2015 and the second occlusion was noted on (b)(6) 2015.Additional information received on (b)(4) 2015: it was reported that the patient had passed away.The cause of death is unknown, however, the physician does not believe that the ultraflex esophageal ng stent was related to the patient's death.Additional information received on (b)(4) 2015: the physician reported that the cause of death was due to esophageal cancer.According to the physician, the ultraflex esophageal ng stent was rinsed twice on (b)(6) 2015.After the stent was rinsed the patient was able to eat a liquid food diet orally for a while.A ct scan was performed on (b)(6) 2015 and chest ascites were noted.The patient's overall condition became worse on (b)(6) 2015 and the patient died on (b)(6) 2015.In the physician's assessment, the patient died due to the progression of esophageal cancer and even if there were no device malfunction, the result would not have changed.An autopsy was not performed.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5036934
• MDR Text Key: 24347753
• Report Number: 3005099803-2015-02459
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/09/2017
• Device Model Number: M00513710
• Device Catalogue Number: 1371
• Device Lot Number: 0017687190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR