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

Model Number M00564840

Device Problems Failure to Advance (2524); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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 (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was used to treat an airway obstruction and dyspnea caused by compression of metastatic lymph nodes during an airway stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was difficult to cross the lesion and the stent was unable to fully deploy.The stent was removed and the procedure was completed with another ultraflex tracheobronchial stent.Per review of photos received from the complainant of the device, the stent was fully deployed; however, the stent failed to expand at one end.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: problem code 3270 captures the reportable event of stent failure to expand.Block h10: an ultraflex tracheobronchial distal release covered stent and delivery system were received for analysis.The stent was received completely deployed.Visual and microscopic inspection were performed and it was found that the loops of the stent were bent.Also, the shaft was kinked located approximately 60cm from the tip.The outer diameter and length of the stent were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent failure to expand was not confirmed.Taking all available information into consideration, the investigation concluded that the reported event of stent failure to expand and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, and/ or the anatomy of the patient (if stricture is too tight) could have caused the physician to apply force to cross the stricture, which limited the performance of the device and contributed to the failure reported and the observed damaged on the stent loop and delivery system.Therefore, the most probable 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.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / product label.Block h11: correction- block d4 (lot number, expiration date) and block h4 (device manufacture date) have been corrected.Per the complainant the previously reported lot number was incorrect and the correct lot is unknown.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.

Event Description

It was reported to boston scientific corporation on (b)(6), 2020 that an ultraflex tracheobronchial covered distal release stent was used to treat an airway obstruction and dyspnea caused by compression of metastatic lymph nodes during an airway stenting procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the device was difficult to cross the lesion and the stent was unable to fully deploy.The stent was removed and the procedure was completed with another ultraflex tracheobronchial stent.Per review of photos received from the complainant of the device, the stent was fully deployed; however, the stent failed to expand at one end.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 TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10251319
• MDR Text Key: 198137848
• Report Number: 3005099803-2020-02715
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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: 09/08/2021
• Device Model Number: M00564840
• Device Catalogue Number: 6484
• Device Lot Number: 0024395869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 45