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

Model Number M00513740

Device Problems Failure to Advance (2524); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 july 10, 2020 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant tumor in the esophagus during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure post patient sedation, the stent was unable to cross the stenosis.Reportedly, the procedure was not completed due to device availability and the physician estimated that the patient may not endure a prolonged procedure.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 july 10, 2020 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant tumor in the esophagus during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure post patient sedation, the stent was unable to cross the stenosis.Reportedly, the procedure was not completed due to device availability and the physician estimated that the patient may not endure a prolonged procedure.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: device problem code 3191 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 returned fully covered and undeployed.Visual inspection was performed and it was found that the loops of the stent were bent.Functional evaluation revealed the stent was deployed without any issue by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.The outer diameter of the stent was measured and was found to be within specification.No other issues were noted to the stent and delivery system.The reported event of delivery system difficult to cross lesion was not confirmed, the issue occurred during the procedure and it is not possible to replicate in the laboratory.The investigation concluded that the reported event was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, and/or the patient's tight anatomy, limited the performance of the device.Also, not lubricating the distal tip may contribute to the delivery system difficulty crossing the lesion.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause for this failure.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/ 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: 10349647
• MDR Text Key: 209153801
• Report Number: 3005099803-2020-03077
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• 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: 09/18/2020

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: 08/09/2020
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0022496159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60