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

Model Number	M00513840
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-06336 and 3005099803-2021-06337 for the associated device information.It was reported to boston scientific corporation on november 15,2021 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 12 cm malignant esophageal stenosis during a gastroscopy procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, there was difficulty advancing the delivery system of a 15cm ultraflex esophageal stent (the subject of mfr.Report # 3005099803-2021-06336) through the stricture.The distal part of the delivery system was bent the stent was deployed in an incorrect location.It was observed under direct visualization with a pediatric gastroscope that the stent did not fully expand.The stent was removed from the patient using a re-usable grasping forceps.A 10 cm ultraflex esophageal stent (subject of this report) was attempted to be deployed, but similar problems occurred; the delivery system had difficulty advancing through the stricture, the distal part of the delivery system was bent, the stent was deployed in an incorrect location and the stent did not fully expand.The 10 cm ultraflex esophageal stent was removed from the patient using re-usable grasping forceps and the procedure was cancelled and rescheduled due to device availability.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b1, b2 (outcomes attribute to adverse event), b5, e1 (initial reporter's first name), h1 and h6 (impact codes) have been updated with additional information received on (b)(6), 2021.Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Medical device problem code a150101 captures the reportable event of stent failure to expand.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.Block h11: block g2 (report source) has been corrected.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-06336 and 3005099803-2021-06337 for the associated device information.It was reported to boston scientific corporation on (b)(6),2021 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 12 cm malignant esophageal stenosis during a gastroscopy procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, there was difficulty advancing the delivery system of a 15cm ultraflex esophageal stent (the subject of mfr.Report # 3005099803-2021-06336) through the stricture.The distal part of the delivery system was bent the stent was deployed in an incorrect location.It was observed under direct visualization with a pediatric gastroscope that the stent did not fully expand.The stent was removed from the patient using a re-usable grasping forceps.A 10 cm ultraflex esophageal stent (subject of this report) was attempted to be deployed, but similar problems occurred; the delivery system had difficulty advancing through the stricture, the distal part of the delivery system was bent, the stent was deployed in an incorrect location and the stent did not fully expand.The 10 cm ultraflex esophageal stent was removed from the patient using re-usable grasping forceps and the procedure was cancelled and rescheduled due to device availability.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021*** it is unknown if the 10cm ultraflex esophageal stent was removed from the patient.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: 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: 12960101
• Report Number: 3005099803-2021-06337
• Device Sequence Number: 19296365
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0027493567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male