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

Model Number M00513750

Device Problems Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; 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 (b)(6) 2021 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant stricture in the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the deployment suture would not release.The stent was partially deployed on the delivery system when it was removed from the patient.Reportedly, the procedure was not completed because the same device was unavailable at the time of the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the shaft was kinked and the deployment suture was returned tangled up over the shaft.Microscopic inspection was performed and it was noted that the stent cover was damaged.Functional examination was performed, and the shaft bowed during deployment.The stent was found deformed; the outer diameter of the stent was measured and the middle section was found smaller than the specification.No other issues were noted to the stent and the delivery system.The reported event of stent partially deployed was confirmed.The damages noted to the returned device may likely be due to anatomical and procedural factors encountered during the procedure.The amount of force applied to the delivery system and the resistance felt during the procedure could have contributed to the kinks noted in the shaft, stent cover damage, and could have caused the tangled suture.Additionally, the stent being partially deployed could have caused the deformation of the stent after manual deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation on january 04, 2021 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant stricture in the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the deployment suture would not release.The stent was partially deployed on the delivery system when it was removed from the patient.Reportedly, the procedure was not completed because the same device was unavailable at the time of the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 11214904
• MDR Text Key: 228356604
• Report Number: 3005099803-2021-00167
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0025219672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1