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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGILE ESOPHAGEAL OTW; PROSTHESIS, ESOPHAGEAL

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BOSTON SCIENTIFIC CORPORATION AGILE ESOPHAGEAL OTW; PROSTHESIS, ESOPHAGEAL Back to Search Results
Device Problems Break (1069); Off-Label Use (1494); Device-Device Incompatibility (2919); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  Injury  
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a0401 captures the reportable event of stent suture break.
 
Event Description
It was reported to boston scientific corporation that an agile esophageal stent was to be implanted in the esophagus during an esophageal stent placement and suture stent fixation (overstitch) procedure performed on an unknown date.During the procedure, the stent was successfully deployed.However, the physician was not able to remove the scope and overstitch device due to the sutures being entangled.The scope was removed by pulling on both the overstitch suture and the stent purse string at which both sutures broke, which also caused the stent to be dislodged.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that during an esophageal stent placement procedure an agile stent and overstitch suture fixation device were to be used.However, per the agile esophageal 23mm otw project e0644, there is sufficient published evidence in the literature to support that the use of standard clips, endoscopic suturing, and over-the-scope clip decreases stent migration but does not eliminate it.
 
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Brand Name
AGILE ESOPHAGEAL OTW
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 Key19175078
MDR Text Key340954597
Report Number3005099803-2024-01739
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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