MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564840

Device Problems Break (1069); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  Injury  

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 (b)(6) 2019 that an ultraflex tracheobronchial covered distal stent was to be used to treat a tumor during a tracheal stent implantation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed.However, it was noticed that the stent shifted downwards, the stent retention suture was fractured and the stent was deformed.The stent was removed with forceps and another ultraflex tracheobronchial stent was implanted to complete 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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial covered distal stent was to be used to treat a tumor during a tracheal stent implantation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed.However, it was noticed that the stent shifted downwards, the stent retention suture was fractured and the stent was deformed.The stent was removed with forceps and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient compliations 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 e1: initial reporter's address: the cross of jingsan and weiwu road dongjiao.Block h6: problem code 1069 to capture the reportable event of stent retention suture break.Problem code 3009 to capture the reportable event of stent positioning issue.Problem code 2976 to capture the reportable event of stent deformed.Block h10: an ultraflex tracheobroncial covered stent was received for analysis; the delivery system was not returned.Visual examination found the stent was received deployed, unraveled, and, expanded.One of the green retention sutures was broken.The stent was measured to be within specification.No other issues with the stent were noted.The damages noted to the returned device may have happened due to manipulation, excessive handling or resistance during stent deployment.The investigation concluded that the reported event and the observed failures are most likely due to procedural factors such as handling of the device, the technique used by the user and nomal procedural difficulties encountered during the procedure may have limited the device performance.Therefore, the most probabale 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 TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8693534
• MDR Text Key: 147853598
• Report Number: 3005099803-2019-03014
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K012883
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: M00564840
• Device Catalogue Number: 6484
• Device Lot Number: 0022758754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75