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

Model Number M00513750

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2019

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on july 8, 2019 that an ultraflex esophageal ng distal release covered stent was to be used to treat a 6 cm stricture in the esophagus due to esophageal cancer with tracheoesophageal fistula during an esophageal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent deployment suture was stuck and could not be pulled further.The stent was partially deployed when removed from the patient.A photo was provided and showed a small hole in the distal stent cover.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result this event.Tha patient's condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on july 8, 2019 that an ultraflex esophageal ng distal release covered stent was to be used to treat a 6 cm stricture in the esophagus due to esophageal cancer with tracheoesophageal fistula during an esophageal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent deployment suture was stuck and could not be pulled further.The stent was partially deployed when removed from the patient.A photo was provided and showed a small hole in the distal stent cover.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a resul this event.Tha patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter phone: (b)(6).Block h6: problem code 2978 captures the reportable event of stent cover damaged.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.Visual analysis of the returned device found the stent was received partially deployed.A photo was provided and showed a hole at the distal end of the stent, also a significant quantity of blood was noted at the stent, however, upon product analysis no issues were noted with the stent cover.Functional evaluation revealed that it was possible to deploy the stent by manually pulling the finger ring to release with no difficulty.The stent was measured and was found to be within specifications.No other issues with the stent and delivery system were noted.The reported failure of stent cover damage could not be confirmed.Device analysis identified no damage to the stent cover.Possibly, the supposed hole found in the photo is not an actual hole but an effect caused by blood.The stent was received partially deployed.Taking all available information into consideration, the investigation concluded that the reported event was likely due to anatomical or procedural factors such as, characteristics of the lesion, handling of the device, the technique used by the user and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to procedure.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.

• 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: 8861962
• MDR Text Key: 153688751
• Report Number: 3005099803-2019-03792
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2020
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0022228859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 45