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

Catalog Number 28-M344250402690U

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

Patient Problems Aneurysm (1708); Weakness (2145)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under this mdr report #.Device 2 is being reported under mdr 2247858-2019-00018.

Event Description

"patient presented with large thoracic aortic aneurysm.Tevar was performed (b)(6) 2019.Patient had a pre-existing open abdominal aneurysm repair (open graft).Graft was landed approximately 4cm above celiac.Patient received a spinal drain.Patient was discharged without incident.Patient presented in er with lower extremity weakness on (b)(6) 2019." patient outcome: "patient was admitted to er.".

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2019-00017.Device 2 is being reported under mdr 2247858-2019-00018.- attachment: [mdr 2247858-2019-00017 - device 1 follow-up evaluation.Pdf].

Event Description

"patient presented with large thoracic aortic aneurysm.Tevar was performed (b)(6) 2019.Patient had a pre-existing open abdominal aneurysm repair (open graft).Graft was landed approximately 4cm above celiac.Patient received a spinal drain.Patient was discharged without incident.Patient presented in er with lower extremity weakness on (b)(6) 2019.".Patient outcome: "patient was admitted to er.".

• 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
• MDR Report Key: 8510626
• MDR Text Key: 141817848
• Report Number: 2247858-2019-00017
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

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: 12/06/2021
• Device Catalogue Number: 28-M344250402690U
• Device Lot Number: 171206228
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR