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

Model Number M00564780

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex tracheobronchial distal release covered stent was to be implanted in the lungs to treat a malignant stricture during a stent placement procedure performed on (b)(6), 2017.Reportedly, patient¿s anatomy was not tortuous but was dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent, however, the stent failed to expand.The physician attempted to dilate the stent with a balloon but was unsuccessful.The physician removed the stent using forceps and the procedure was completed with another ultraflex tracheobronchial stent.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 was returned for analysis, the delivery system was not returned.Visual analysis found the stent was not fully expanded.The stent failed to expand after it was incubated at 37c for 24 hours.High heat exposure to the stent cover was noted under magnification inspection.No other issues were identified with the device.Device analysis determined that the condition of the returned device was consistent with the complaint incident as the stent was not possible to expand.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping.Therefore, the most probable root cause is handling damage.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 labeling review was performed and, from the information available, this device was used in a manner inconsistent per the directions for use (dfu) / product label.The dfu states; the ultraflex tracheobronchial covered stent should be stored in a cool, dry, dark place and do not exceed 40 °c (104 °f).The condition of the stent covering on the returned device is consistent with high heat exposure.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex tracheobronchial distal release covered stent was to be implanted in the lungs to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2017.Reportedly, patient¿s anatomy was not tortuous but was dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent, however, the stent failed to expand.The physician attempted to dilate the stent with a balloon but was unsuccessful.The physician removed the stent using forceps and the procedure was completed with another ultraflex tracheobronchial stent.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: 6283010
• MDR Text Key: 65946665
• Report Number: 3005099803-2017-00058
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

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: 06/20/2018
• Device Model Number: M00564780
• Device Catalogue Number: 6478
• Device Lot Number: 19389269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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
• Patient Age: 62 YR
• Patient Weight: 52