MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH DYNAMIC Y STENT; PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC

Model Number M00570680

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Code Available (3191)

Event Date 06/09/2017

Event Type  Death  

Manufacturer Narrative

The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.The patient was initially seen at (b)(6) hospital.The patient was referred out to a specialist, dr.(b)(6), where the dynamic y stent was implanted.After the patient went into arrest, the patient was taken to (b)(6) hospital, and was then transferred to (b)(6)hospital, where the patient was under the care of dr.(b)(6).(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 that a dynamic y stent was successfully implanted to treat excessive dynamic airway collapse (edac) during a bronchoscopy procedure on (b)(6) 2017.The patient was kept for observation for 3 days post procedure and was reported to be fine at that time.On (b)(6) 2017, the patient was found on the floor of their home in arrest.The patient was taken to the hospital, treated, and then transferred to another hospital.The patient then died while at this hospital.Reportedly, the physician is not sure if the dynamic y stent is related to the patient's arrest and death.The patient's cause of death was not reported.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information received on september 01, 2017.The physician mentioned in the additional information is dr.(b)(6) of (b)(6).

Event Description

It was reported to boston scientific corporation that a dynamic y stent was successfully implanted to treat excessive dynamic airway collapse (edac) during a bronchoscopy procedure on (b)(6) 2017.The patient was kept for observation for 3 days post procedure and was reported to be fine at that time.On (b)(6) 2017, the patient was found on the floor of their home in arrest.The patient was taken to the hospital, treated, and then transferred to another hospital.The patient then died while at this hospital.Reportedly, the physician is not sure if the dynamic y stent is related to the patient's arrest and death.The patient's cause of death was not reported.Additional information received on september 01, 2017: a physician familiar with the case speculated that, during the placement procedure, the dynamic y stent may have been modified incorrectly, allowing it to move within the trachea.However, the physician did not see any evidence to indicate that the stent had moved out of position or that there was any issue with the stent.

• Brand Name: DYNAMIC Y STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): WILLY RUESCH GMBH; willy ruesch strasse 4-10; kernen 71394
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6802121
• MDR Text Key: 82959830
• Report Number: 3005099803-2017-02463
• Device Sequence Number: 0
• Product Code: JCT
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00570680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 09/20/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death