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

Model Number M00564870

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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) 2015, that an ultraflex tracheobronchial distal release covered stent was implanted in the trachea during a stent placement procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 4cm malignant obstruction.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, the physician removed an ultraflex tracheobronchial stent that had been previously placed on an unknown date and was found to have migrated due to the decline in size of the tumor after therapy.The physician then implanted an 18mm x 6cm ultraflex tracheobronchial distal release covered stent.There were no issues noted and the stent was implanted successfully.Per the physician, the stent was not dilated after placement.On (b)(6) 2015, the patient informed the physician that he coughed up five pieces of metal that were believed to be part of the 18mm x 6cm ultraflex tracheobronchial distal release covered stent.A diagnostic bronchoscopy procedure was performed on (b)(6) 2015 and it was confirmed that the metal pieces were part of the 18mm x 6cm ultraflex tracheobronchial distal release covered stent that was placed on (b)(6) 2015.The remainder of the stent was removed using a stent grasper and rat tooth 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

An ultraflex tracheobronchial stent and five wire pieces were returned for analysis.A visual examination of the returned device components noted the stent had multiple fractures and the stent suture at one end was broken.The delivery system of the device was not received for analysis.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label."stent fracture" is a known complication associated with the use of this device, and is listed in the directions for use (dfu) / product label.Therefore, the root cause of this complaint is anticipated procedural complication.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015, that an ultraflex tracheobronchial distal release covered stent was implanted in the trachea during a stent placement procedure performed on (b)(^) 2015.According to the complainant, this was to treat a 4cm malignant obstruction.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, the physician removed an ultraflex tracheobronchial stent that had been previously placed on an unknown date and was found to have migrated due to the decline in size of the tumor after therapy.The physician then implanted an 18mm x 6cm ultraflex tracheobronchial distal release covered stent.There were no issues noted and the stent was implanted successfully.Per the physician, the stent was not dilated after placement.On (b)(6) 2015, the patient informed the physician that he coughed up five pieces of metal that were believed to be part of the 18mm x 6cm ultraflex tracheobronchial distal release covered stent.A diagnostic bronchoscopy procedure was performed on (b)(6) 2015 and it was confirmed that the metal pieces were part of the 18mm x 6cm ultraflex tracheobronchial distal release covered stent that was placed on (b)(6) 2015.The remainder of the stent was removed using a stent grasper and rat tooth 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.

• 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: 5311710
• MDR Text Key: 33905939
• Report Number: 3005099803-2015-03542
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: ZA
• 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: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2017
• Device Model Number: M00564870
• Device Catalogue Number: 6487
• Device Lot Number: 17879468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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
• Patient Age: 39 YR