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

Model Number M00513730

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported event of stent partially deployed.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)(4) 2015 that an ultraflex esophageal ng distal release stent was used to treat a 7 cm malignant tumor in the first part of the esophagus during a stent placement procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to the stent placement procedure.During the procedure, after 2cm of the stent was deployed it got stuck and the physician was unable to fully release the stent.The ultraflex esophageal ng stent was removed from the patient partially deployed on the delivery system.It was noted that the patient experienced some bleeding, but that the bleeding resolved on its own without treatment.The procedure was completed with a different device.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

An ultraflex¿ esophageal ng stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was partially deployed.Functional analysis found that the remainder of the stent was not possible to deploy by pulling on the pull ring.However, it was possible to deploy the crochet knots by manually pulling on the suture adjacent to the knot itself, indicating that knots in the suture crocheting was not the cause of the issue.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident, the stent was received partially deployed.However, 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.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 search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on november 26, 2015 that an ultraflex esophageal ng distal release stent was used to treat a 7 cm malignant tumor in the first part of the esophagus during a stent placement procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to the stent placement procedure.During the procedure, after 2cm of the stent was deployed it got stuck and the physician was unable to fully release the stent.The ultraflex esophageal ng stent was removed from the patient partially deployed on the delivery system.It was noted that the patient experienced some bleeding, but that the bleeding resolved on its own without treatment.The procedure was completed with a different device.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: 5311066
• MDR Text Key: 33890001
• Report Number: 3005099803-2015-03543
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2017
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 18423679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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