MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564850

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on july 03, 2017 that an ultraflex¿ tracheobronchial distal release stent was used to treat a malignant stricture in the bronchus during a stent placement procedure performed on (b)(6)2017.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the stent was ¿stuck¿ after being partially deployed and was removed from the patient.No other stent was available at the time and the partially deployed stent was reinserted into the patient, and was deployed (¿replanted¿) successfully using the delivery system.One day post stent placement, the stent failed to expand and was confirmed to have migrated thru endoscopic retrograde cholangiopancreatography (ercp).The stent was removed from the patient using a forceps.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

Additional information received on august 8, 2017: block updated.Investigation results: a fully deployed ultraflex tracheobronchial distal release covered stent was received for analysis; the delivery system was not returned.The stent was measured to be within specifications.No issues were identified with the device.The condition of the returned device could not confirm the reported event.The investigation concluded that the reported event was likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on july 03, 2017 that an ultraflex¿ tracheobronchial distal release stent was used to treat a malignant stricture in the bronchus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the stent was ¿stuck¿ after being partially deployed and was removed from the patient.No other stent was available at the time and the partially deployed stent was reinserted into the patient, and was deployed (¿replanted¿) successfully using the delivery system.One day post stent placement, the stent failed to expand and was confirmed to have migrated thru endoscopic retrograde cholangiopancreatography (ercp).The stent was removed from the patient using a forceps.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.**additional information received on august 8, 2017: the stent migration was confirmed through imaging, not ercp.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6727916
• MDR Text Key: 80537289
• Report Number: 3005099803-2017-02179
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

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: 12/09/2018
• Device Model Number: M00564850
• Device Catalogue Number: 6485
• Device Lot Number: 20059588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention