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

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

Patient Problems Anemia (1706); 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 events: hematoma and bleeding the product code and event date were unknown.Procedure: tevar (thoracic endovascular aortic repair) was performed using a relay plus stent graft system.Y-type artificial blood vessel replacement was also performed at the same time.Patient outcome: about four months after the above tevar and vessel replacement procedure, the following symptoms appeared to the patient: the right leg was swelling and its color appeared abnormal, and a hematoma inside the muscle of the right leg was observed by ct scanning.Since anemia was also confirmed, the patient was hospitalized for treatment.Endleak from the relay plus graft was not definitely confirmed.The state of the blood indicated to be possibly the disseminated intravascular coagulation syndrome (dic).The patient was administered heparin.Even if the condition improved, bleeding from the wound site was observed again, that is, the outcome was not stable.The patient started oral administration of tranexamic acid.The state of the blood was not completely improved, but re-bleeding was not observed.The patient was therefore discharged from the hospital.".

• 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: 7696581
• MDR Text Key: 114279443
• Report Number: 2247858-2018-00142
• 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: 71 YR