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

Model Number M00514200

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on november 16, 2020 that an ultraflex esophageal ng distal covered stent was implanted to treat a stenosis in the esophagus during a stent placement procedure performed on (b)(6) 2020.According to the complainant, the stent was deployed successfully.X-ray imaging was performed 24 hours post stent placement and it was confirmed that the stent was placed in the target location; however, on (b)(6) 2020, imaging was performed and it was noted that the stent had migrated almost into the patient's stomach.Reportedly, the stent was removed and the procedure was completed with another ultraflex esophageal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex esophageal ng distal covered stent was implanted to treat a stenosis in the esophagus during a stent placement procedure performed on (b)(6) 2020.According to the complainant, the stent was deployed successfully.X-ray imaging was performed 24 hours post stent placement and it was confirmed that the stent was placed in the target location; however, on (b)(6) 2020, imaging was performed and it was noted that the stent had migrated almost into the patient's stomach.Reportedly, the stent was removed and the procedure was completed with another ultraflex esophageal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter's facility name: (b)(6).Block h6: patient code 3191 is being used to capture the secondary procedure performed to remove the migrated stent.Device problem code 4003 captures the reportable event of stent migration.Block h10: an ultraflex esophageal covered stent was received for analysis; the delivery system was not returned.Visual inspection was performed and the loops of the stent were found bent.No other issues were noted to the stent.The reported event of stent migration was not confirmed as it is impossible to replicate the failure reported occurred during the procedure on the laboratory during analysis of the device.It is most likely that the factors encountered during the procedure, the patient's anatomy, and the technique used by the user during the stent placement could have caused the migration into the patient's stomach.Additionally, the stent loops were bent; however, there is insufficient information about what could be the cause for this failure.Stent migration is noted within the ifu as a known potential adverse event related to the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10967510
• MDR Text Key: 220200381
• Report Number: 3005099803-2020-05905
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729121190
• UDI-Public: 08714729121190
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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
• Device Expiration Date: 11/10/2021
• Device Model Number: M00514200
• Device Catalogue Number: 1420
• Device Lot Number: 0024745046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 74