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

Model Number M00564770

Device Problems Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

(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)(4) 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a stenosis in the left main bronchus due to lung cancer during a tracheal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to expand and moved to the distal end of bronchus.The stent was removed with forceps and the procedure was completed with another ultraflex tracheobronchial 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

Problem code 3270 captures the reportable event of stent failed to expand.Problem code 3009 captures the reportable event of stent positioning issue.An ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was received fully deployed off the delivery system and expanded.The stent was measured to be within specifications.No other issues were noted to the stent.The stent was received deployed and expanded.As there was no issue with the device visual test during product analysis, the stent failure to expand complaint cannot be confirmed.The investigation concluded that the reported events were likely due to anatomical or procedural factors, such as characteristics of the lesion, the handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure which may have limited the performance of the device.Therefore, the most probable root cause is adverse event related to the 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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a stenosis in the left main bronchus due to lung cancer during a tracheal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to expand and moved to the distal end of bronchus.The stent was removed with forceps and the procedure was completed with another ultraflex tracheobronchial 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.

• 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: 8658535
• MDR Text Key: 146657104
• Report Number: 3005099803-2019-02738
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: M00564770
• Device Catalogue Number: 6477
• Device Lot Number: 0021469887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 68