MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513750

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problems Vomiting (2144); No Code Available (3191)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter's address 1: (b)(6).(b)(4).The complainant indicated that the device remains implanted and 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.

Event Description

It was reported to boston scientific corporation on august 18, 2020 that an ultraflex esophageal ng distal release covered stent was implanted to treat a malignant stricture at the mid to distal esophagus during a stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was dilated with cre (controlled radial expansion) balloon prior to stent placement.According to the complainant, during the procedure, a 15cm ultraflex esophageal stent was successfully placed stent in stent with another ultraflex esophageal stent.Reportedly, 4 days post stent placement, the patient presented with vomiting.Endoscopy was performed and a pediatric scope was used to access the stricture.It was found out that the 15 cm stent did not fully expand and severe kinking was observed.The stent had wires protruding towards the middle of the stent.Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in placed.The physician placed a ryles tube in the stomach while the patient was under observation before the re-stenting procedure.An 18mm x 15 cm wallflex fully covered stent was placed over the damaged ultraflex stent to complete the procedure.Reportedly, the wallflex stent has effectively opened up against the damaged ultraflex stent and the stricture was managed.The patient's condition at the conclusion of the procedure was reported to be stable.The patient was kept under observation until (b)(6) 2020.A photo of the device implanted in the patient provided by the complainant shows the stent failure to expand and stent wires protruding inwards.Reportedly, in the physician's assessment, there was a relationship between the stent kinking and the patient vomiting.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10507007
• MDR Text Key: 206317020
• Report Number: 3005099803-2020-03523
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0024029662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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: 64 YR