MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT-UNI¿ ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M001731550

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

Patient Problems Death (1802); Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 01/24/2017

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that vessel perforation and cardiac tamponade occurred and the patient died.The target lesion was located in the superior vena cava.A 16x90mmx75cm wallstent-uni¿ endoprosthesis was implanted to treat the lesion.However, the patient had severe cardiac tamponade and died.The physician identified that the stent struts perforated through the superior vena cava.

Manufacturer Narrative

Age at time of event, age at time of event (unit), patient sex, describe event or problem updated.(b)(4).

Event Description

It was further reported that there were no problems during placement of the 16x90mmx75cm wallstent-uni¿ endoprosthesis.However, approximately three hours post procedure, the patient had clinical hemodynamic shock and died.Autopsy revealed perforation of the superior caval wall by the distal struts of the wallstent and a hemopericardium of 350ml.The diagnosis was acute cardiac tamponade due to caval wall perforation.

• Brand Name: WALLSTENT-UNI¿ ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6303801
• MDR Text Key: 66595400
• Report Number: 2134265-2017-01131
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K992510
• 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: 01/31/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2017
• Device Model Number: M001731550
• Device Catalogue Number: 73-155
• Device Lot Number: 17854638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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): Death
• Patient Age: 58 YR