MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCUALR GRAFT, AORTIC

Catalog Number 28-M34025036259U

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 05/07/2019

Event Type  Death  

Event Description

"right femoral cutdown (only access) 6,000 units of heparin given ivus (intravascular ultrasound) used to assess true lumen and aortic diameter 100cm marker pigtail and 300cm 4cm extended curve lunderquist wire the procedure was performed in the normal fashion using diagnostic wires and catheters to navigate into the true lumen of the dissection and verifying with ivus.After ivus measurements a 40-36 x 250 graft was selected with the possibility of a second piece.The proximal landing zone was about20- 25mm proximal to the debranch graft at the 3rd chest wire.Positioning and placement of the relay plus graft went as planned with the patient's vital signs stable.During the last deployment step, step 4 the patients blood pressure dropped to a systolic pressure in the mid 30's.Anesthesia gave medication to increase the bp with no improvement chest compressions were started and a code was called.The relay plus was left in place over the wire in the lower descending aorta to maintain hemostasis of the femoral artery during the code.No further imaging or angiograms were done".Patient outcome: "after an extended time of preforming cpr a time of death was called.Dr.(b)(6) spoke with the family and they agreed to an autopsy to determine the cause".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCUALR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 8670188
• MDR Text Key: 147047044
• Report Number: 2247858-2019-00034
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Catalogue Number: 28-M34025036259U
• Device Lot Number: 161020190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2016
• 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): Death
• Patient Age: 68 YR