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

Model Number	M00513750
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the ultraflex esophageal stent will not be returned for evaluation; therefore a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex esophageal ng distal release covered stent was implanted during a procedure performed on an unknown date.On (b)(6) 2022, post stent placement, it was noted that the ultraflex esophageal stent had a partial, distal migration.There were no patient complications reported due to this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks a2 (age at time of event), a3, a4, b1, b2 (outcomes attrib to adv event), b5, d6a, d7b, e1 (initial reporter facility name, address 1, city, country, zip/post code, phone number), e3 (occupation), g2 (report source, report source other), h1, h6 (impact codes), h8 and h10 have been updated with additional information received august 23, 2022 and august 26, 2022.Block h6: medical device problem code a010402 captures the reportable event of ultraflex esophageal stent migration.Impact code f23 is being used to capture the additional intervention of stent repositioning and removal of the migrated ultraflex esophageal stent.Block h10: the complainant indicated that the ultraflex esophageal stent was disposed and will not be returned for evaluation; therefore a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on july 25, 2022 that an ultraflex esophageal ng distal release covered stent was implanted during a procedure performed on an unknown date.On july 01, 2022, post stent placement, it was noted that the ultraflex esophageal stent had a partial, distal migration.There are no known patient complications reported due to this event.Additional information received on august 23, 2022 and august 26, 2022.Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report and 3005099803-2022-04526 for the associated device information.The ultraflex esophageal stent was implanted in the esophagus to treat a 10cm malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on june 30, 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.On july 01, 2022, post stent placement, the ultraflex esophageal stent (the subject of this report) had a partial, distal migration and was repositioned with forceps.The ultraflex esophageal stent remained implanted and the procedure was completed.On july 11, 2022, egd procedure was performed and the ultraflex esophageal stent was removed from the patient with forceps.A second ultraflex esophageal stent (the subject of mfr.Report # 3005099803-2022-04526) was to be implanted; however, "the stent had only opened partially".The second ultraflex esophageal stent was removed from the patient and the procedure was completed with another ultraflex esophageal stent.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on august 30, 2022.Block h6: medical device problem code a010402 captures the reportable event of ultraflex esophageal stent migration.Impact code f23 is being used to capture the additional intervention of stent repositioning and removal of the migrated ultraflex esophageal stent.Block h10: the complainant indicated that the ultraflex esophageal stent was disposed and will not be returned for evaluation; therefore a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on july 25, 2022 that an ultraflex esophageal ng distal release covered stent was implanted during a procedure performed on an unknown date.On (b)(6) 2022, post stent placement, it was noted that the ultraflex esophageal stent had a partial, distal migration.There are no known patient complications reported due to this event.**additional information received on august 23, 2022 and august 26, 2022** note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report # (b)(4) and (b)(4) for the associated device information.The ultraflex esophageal stent was implanted in the esophagus to treat a 10cm malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6).The patient's anatomy was tortuous and was not dilated prior to stent placement.On (b)(6) 2022, post stent placement, the ultraflex esophageal stent (the subject of this report) had a partial, distal migration and was repositioned with forceps.The ultraflex esophageal stent remained implanted and the procedure was completed.On (b)(6) 2022, egd procedure was performed and the ultraflex esophageal stent was removed from the patient with forceps.A second ultraflex esophageal stent (the subject of mfr.Report # (b)(4)) was to be implanted; however, "the stent had only opened partially".The second ultraflex esophageal stent was removed from the patient and the procedure was completed with another ultraflex esophageal stent.**additional information received on august 30, 2022** the previously implanted ultraflex esophageal stent (the subject of this report) had slipped up from the target anatomy.A second ultraflex esophageal stent (the subject of mfr.Report # (b)(4)) was deployed and positioned below the previously implanted ultraflex esophageal stent; however, the second ultraflex esophageal stent (the subject of mfr.Report # (b)(4)) did not fully expand (partially opened).Both ultraflex esophgaeal stents were removed from the patient using grasping forceps.

• 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: 15203117
• Report Number: 3005099803-2022-04525
• Device Sequence Number: 2162096
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: GM
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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: 02/01/2023
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0026727492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 08/30/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/29/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 78 KG