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

Model Number M00513840

Device Problems Partial Blockage (1065); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

Udi= (b)(4).Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and 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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex esophageal ng proximal release stent was implanted in the esophagus during a stent procedure performed on (b)(6) 2015.According to the complainant, the stent was implanted to treat a benign fistula after mucosectomy.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, there were no issues encountered in the initial stent placement.However, during an endoscopy procedure performed on unknown date to check the stent, it was found that the stent cover was damaged and there was tissue ingrowth.On (b)(6) 2015, the stent was removed and the patient was sent home.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.

Manufacturer Narrative

A deployed damaged ultraflex esophageal ng stent was received for analysis.An examination of the returned device noted that the stent cover was torn at various locations along its length.An examination of the stent found that one of the stent wires was pulled out and loose.The stent itself was compressed and inverted at one end and folded over itself at the other end.This damage to the stent and possibly the stent cover occurred during the retrieval from the patient after its initial deployment.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.  a labeling review was performed and from the information available, this device was used in a manner inconsistent with the labeled indications.The dfu states; ¿the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.'' in this case, this device was used to treat a benign fistula after a mucosectomy.Therefore, the most probable root cause classification is user/use error.

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that an ultraflex esophageal ng proximal release stent was implanted in the esophagus during a stent procedure performed on (b)(6) 2015.According to the complainant, the stent was implanted to treat a benign fistula after mucosectomy.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, there were no issues encountered in the initial stent placement.However, during an endoscopy procedure performed on unknown date to check the stent, it was found that the stent cover was damaged and there was tissue ingrowth.On (b)(6) 2015, the stent was removed and the patient was sent home.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.

• 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: 5159919
• MDR Text Key: 28672710
• Report Number: 3005099803-2015-02952
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2017
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0018054212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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