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

Catalog Number 28-M336190322490U

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

Patient Problems Death (1802); Ischemia (1942); Weakness (2145)

Event Date 08/09/2019

Event Type  Death  

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr.Device 2 is being reported under mdr 2247858-2019-00064.

Event Description

"the patient was doing well and had been released to leave the hospital when he began to feel some left sided weakness.They then re-admitted him for spinal cord ischemia and bumped up his pressure there on the spot.When the pressure was dramatically raised the patient had a rtad and subsequently died from this.The cts that implanted the grafts stayed up all throughout the evening of the 8th and into the morning of the 9th trying to save the patient but the patient expired on the morning of the 9th." patient outcome: "pt died from a rtad".

Event Description

"the patient was doing well and had been released to leave the hospital when he began to feel some left sided weakness.They then re-admitted him for spinal cord ischemia and bumped up his pressure there on the spot.When the pressure was dramatically raised the patient had a rtad and subsequently died from this.The cts that implanted the grafts stayed up all throughout the evening of the 8th and into the morning of the 9th trying to save the patient but the patient expired on the morning of the 9th." patient outcome: "pt died from a rtad".Email received on 08/12/2019 from (b)(6), terumo aortic endovascular consultant, "no autopsy.No.Physician believes we had a great result.The rtad was unrelated to the graft.".

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2019-00063.Device 2 is being reported under mdr 2247858-2019-00064.- attachment: [mdr 2247858-2019-00063 - device 1 follow-up evaluation.Pdf].

• 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: 8949639
• MDR Text Key: 156114879
• Report Number: 2247858-2019-00063
• 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: 09/27/2019

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: 08/06/2021
• Device Catalogue Number: 28-M336190322490U
• Device Lot Number: 170808259
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR