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

Model Number M00513860

Device Problems Partial Blockage (1065); Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event of stent blocked/occluded.Reported event of stent difficult to remove.Reported event of stent broken.Reported event of stent cover damaged.Reported event of stent cover detached.Although expected, the device at issue in this complaint has not yet been received for evaluation; therefore, a failure analysis is not available.At this time, we are unable to determine the relationship between the device and the cause for this event.If there is any further relevant information received, a supplemental medwatch report will be filed.

Event Description

It was reported to boston scientific corporation that a covered ultraflex¿ esophageal ng stent was implanted during a procedure performed on (b)(6) 2015.According to the complainant, the stent was implanted to treat an esophageal stricture resulting from a tumor.The patient returned unable to eat in (b)(6) 2015, and it was determined that another esophageal stricture was present due to further growth of the tumor.On (b)(6) 2015, a second covered ultraflex¿ esophageal ng stent was implanted without issue slightly proximal to the first stent.The patient later returned to the hospital, reportedly unable to eat.During an endoscopy procedure, the physician noted that the second stent was blocked and appeared to curl on itself.The physician also noted that the cover of the stent was out of place.During an attempted stent removal procedure on (b)(6) 2015, the physician experienced difficulty removing the second stent and was unable to do so.The stent was successfully removed from the patient during a second stent removal procedure performed on (b)(6) 2015.It was noted upon removal that the stent was broken into several pieces and that the cover of the stent was damaged and was not attached to the stent.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.

Manufacturer Narrative

An ultraflex esophageal ng stent was returned for analysis.The stent appeared as if removal was attempted by pulling the distal end of the stent through the inner lumen of the stent, resulting in the distal part of the stent and associated cover being inside the stent lumen.The stent cover was still attached to the proximal end of the stent but detached from the distal end.Some wire pieces could be seen attached to the distal end of the stent cover.The distal end of the stent pulled into the inner lumen of the stent appeared tangled together.The stent cover appeared discolored.The retrieval suture at the proximal end of the stent was intact.Stent fracture, tumor in-growth through the stent, and tumor overgrowth around ends of the stent are known post-stent placement complications associated with the use of this device, and are listed in the directions for use (dfu) / product label.Therefore, the root cause of this complaint is anticipated procedural complication.A labeling review was performed, and there was evidence the device was not used in accordance with the labeling.The dfu states; recurrence or worsening of dysphagia may occur after stent placement due to tumor in growth or overgrowth, severe hyperplasia reaction or stent migration.Repeat endoscopy may be required.¿ the dfu also states; ¿the ultraflex esophageal ng stent system is not intended to be moved or removed once it is deployed.Moving the deployed stent may break the stent wire or dislodge the cover.If it is necessary to move or remove the stent, it should be done only during the initial stent placement procedure and prior to balloon dilatation using an atraumatic retrieval device to grasp the suture threaded around the stent end.¿ 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 that a covered ultraflex esophageal ng stent was implanted during a procedure performed on (b)(6) 2015.According to the complainant, the stent was implanted to treat an esophageal stricture resulting from a tumor.The patient returned unable to eat in (b)(6) 2015, and it was determined that another esophageal stricture was present due to further growth of the tumor.On (b)(6) 2015, a second covered ultraflex esophageal ng stent was implanted without issue slightly proximal to the first stent.The patient later returned to the hospital, reportedly unable to eat.During an endoscopy procedure, the physician noted that the second stent was blocked and appeared to curl on itself.The physician also noted that the cover of the stent was out of place.During an attempted stent removal procedure on (b)(6) 2015, the physician experienced difficulty removing the second stent and was unable to do so.The stent was successfully removed from the patient during a second stent removal procedure performed on (b)(6) 2015.It was noted upon removal that the stent was broken into several pieces and that the cover of the stent was damaged and was not attached to the stent.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.

• 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: 5371195
• MDR Text Key: 36194367
• Report Number: 3005099803-2016-00030
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 18197593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention