MAUDE Adverse Event Report: WILLY RUESCH GMBH DYNAMIC Y STENT; PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC

Model Number M00570680

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 05/12/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a dynamic y stent was used in the trachea during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a malignant lesion and an ulcer in the left main stem bronchus.Reportedly, the patient¿s anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the physician was able to deploy the stent.The physician noted that the patient was getting air around the stent but not through it.Following deployment, the ulcer started bleeding in the distal trachea and blood started to fill up around the bottom of the stent blocking the air flow.The physician performed suction to the bleed and then chose to remove the stent.The physician was unable to remove the stent with both rigid and flexible graspers.The physician performed a tracheotomy to remove the stent and refine the airway to reestablish normal airflow.Following the procedure, the patient was in the intensive care unit with close monitoring.Reportedly, the bleeding has been resolved.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date (b)(6).Tracheotomy surgery performed.Reported event of stent positioning problem.Reported event of stent difficult to remove.The complainant indicated that the device was disposed and will not be returned for evaluation; 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.

• Brand Name: DYNAMIC Y STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC
• Manufacturer (Section D): WILLY RUESCH GMBH; willy ruesch strasse 4-10; kernen 7139 4
• Manufacturer (Section G): WILLY RUESCH GMBH; willy ruesch strasse 4-10; kernen 7139 4
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3845094
• MDR Text Key: 4680803
• Report Number: 3005099803-2014-02144
• Device Sequence Number: 1
• Product Code: NYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M00570680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Weight: 50