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

Model Number UNK448

Device Problems Component Missing (2306); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an ultraflex covered esophageal stent was implanted within the esophagus during a stent placement procedure performed on (b)(6) 2014.According to the complainant, following a transthoracic esophageal cardia resection, the stent was implanted to treat a leakage near the proximal anastomose site and 23 cm from the incisors.Reportedly, the patient¿s anatomy was not tortuous.On (b)(6) 2014, the physician noted that there was persistent leakage in the patients esophagus.The stent was removed and it was noted that a portion of the stent cover was missing and the remaining cover was damaged.The procedure was completed by implanting another ultraflex esophageal stent at the leakage site.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

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4) for the reported event of stent cover missing.(b)(4) for the reported event of stent cover damage.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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.

Manufacturer Narrative

A visual examination of the returned device found that only the deployed stent was returned for analysis.The stent measured 90mm in length and 23mm in diameter.The stent cover was torn horizontally and longitudinally at several locations along its length.On one side of the stent the cover measured 35mm in length and had no further tears.On another side of the stent the cover was 50mm in length and had several longitudinal tears.The stent cover appeared blue in parts and a section had detached.Device analysis determined that the condition of the returned device was consistent with the complaint incident.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the labeled indications.This device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic or extrinsic malignant tumors only.This device was used to treat a leakage after surgery as a curative intent.Therefore, the most probable root cause classification is user error.A review of the device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.

Event Description

It was reported to boston scientific corporation that an ultraflex covered esophageal stent was implanted within the esophagus during a stent placement procedure performed on (b)(6) 2014.According to the complainant, following a transthoracic esophageal cardia resection, the stent was implanted to treat a leakage near the proximal anastomose site and 23 cm from the incisors.Reportedly, the patient's anatomy was not tortuous.On (b)(6) 2014, the physician noted that there was persistent leakage in the patients esophagus.The stent was removed and it was noted that a portion of the stent cover was missing and the remaining cover was damaged.The procedure was completed by implanting another ultraflex esophageal stent at the leakage site.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
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4334249
• MDR Text Key: 5216701
• Report Number: 3005099803-2014-03966
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K955347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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