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

Model Number M00513860

Device Problem Component Missing (2306)

Patient Problem Fistula (1862)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex esophageal ng proximal release covered stent was implanted to treat an esophageal anastomotic dehiscence during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not dilated prior to stent placement and the patient underwent chemotherapy and radiation prior to the initial surgery.According to the complainant, on (b)(6) 2017, 8 days post stent placement, bile was coming out through the patient¿s intubation tube, which prompted the physician to check the stent.The physician performed an esophagogastroduodenoscopy (egd) procedure and found that a part of the stent cover had disappeared.According to the physician, the stent had failed to resolve the dehiscence and a 4 cm broncho-esophagic fistula was noted.The patient was sent to urgent surgery and the physician performed cervical esophagectomy, gastrostomy, and muscle plasty over the broncho-esophagic fistulae.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: 7119103
• MDR Text Key: 94901001
• Report Number: 3005099803-2017-03817
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2019
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 20309616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• 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