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

Model Number M00564760

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

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)(6) 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture due to tracheal carcinoma that metastasis to esophageal carcinoma during an airway stent implantation procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to expand and several minutes after deployment, the stent moved out of its original position.The stent was removed with snares.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation on march 19, 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture due to tracheal carcinoma that metastasis to esophageal carcinoma during an airway stent implantation procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent failed to expand and several minutes after deployment, the stent moved out of its original position.The stent was removed with snares.There were no patient complications reported as a result of this event.According to the complainant, the procedure was not completed as another stent was not available so the physician decided to complete the procedure at a later date.

Manufacturer Narrative

Block b5 has been updated with additional information received on april 16, 2019.Block h6: (b)(4).Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

• 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: 8509970
• MDR Text Key: 141784236
• Report Number: 3005099803-2019-01704
• 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: 05/09/2019

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: 11/15/2018
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 0019966837
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 78