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

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The device was not returned and no other information is available.Without the delivery system, catalog and lot number and additional information/details, no further investigation can be performed.

Event Description

"adverse event: hematoma.The product code and event date were unknown.Procedure: tevar (thoracic endovascular aortic repair) was performed using a relay plus stent graft system.Patient outcome: about eight months after the above tevar procedure, the following symptoms appeared to the patient: since the right leg was swelling, the patient came to the hospital.A hematoma inside the right quadriceps muscle was observed by ct scanning.The trace of which type ii endoleak from the relay plus graft disappeared was confirmed.The patient started oral administration of tranexamic acid and the re-occurrence of the symptom was not confirmed.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCULAR 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: 7696588
• MDR Text Key: 114284870
• Report Number: 2247858-2018-00143
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/17/2018
• 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): Hospitalization
• Patient Age: 77 YR