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

Model Number M00513750

Device Problems Partial Blockage (1065); Component Missing (2306)

Patient Problem Erosion (1750)

Event Date 12/05/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal covered stent was implanted during a stent placement procedure performed on (b)(6) 2013.According to the complainant, the stent was implanted to treat an esophageal fistula and provide pulmonary gastropleural access.The physician planned to remove the stent once the fistula closed and the patient was placed on a liquid diet.The physician reported that two weeks following stent placement the fistula had closed.On (b)(6) 2013, endoscopy was performed and tissue ingrowth was noted within the stent.On (b)(6) 2013, the stent was removed with great difficulty; causing the patient¿s tissue to tear and bleed.Adrenaline was injected to treat the torn tissue and bleeding, which resolved successfully.Following sent removal, the physician noted that the stent cover was missing from the stent.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

(b)(6).(b)(4).The complainant indicated that the device 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.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3567686
• MDR Text Key: 4216806
• Report Number: 3005099803-2013-15270
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K091816
• 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
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2013
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 14873698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2011
• 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: 29 YR
• Patient Weight: 130