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

Catalog Number 28-M336250322490U

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

Patient Problems Swelling (2091); No Code Available (3191)

Event Date 10/29/2018

Event Type  Injury  

Event Description

"dissection (type b) of the descending aorta.The relay plus thoracic graft, 36/32 x 250, lot # 171228127, was introduced into the right femoral artery and advanced 4/5cm above the celiac artery.The grey deployment grip was pushed forward and the secondary sheath with the graft was advanced to the lsa.Before moving to step 2 on the controller it was pointed out that the grey deployment handle was not up to the black line.The doctor then held the grey deployment knob still while pulling back the black fixed grip until the black line was crossed.The controller was then changed to the 2 position and the doctor exposed the first covered graft segment by sliding the grey deployment grip back.The doctor hand position: right hand on the red mental around 2 inches behind grey deployment grip.Left hand on the grey deployment grip.While under fluoro the left hand slid the grey deployment grip "till" hits his right hand thus exposing the first covered segment.Fluoro was on while final position of the graft was achieved.Happy with the position of the graft, the doctor then slid the grey handle with a "frim" and rapid motion until the grey grip would not move distal any further.Number 3 on the deployment device was next performed by removing the screw and white retainer and sliding the #3 knob distal back towards the wire hub.The proximal clasp released the graft without any issue.#4 on the controller was next moved into position and the stainless steel was gripped and pulled back, moving the nose cone back into the primary sheath.The doctor asked for a 22fr dry seal sheath and i pointed to where the sheath was while the doctor pulled back on the delivery system to remove.The graft moved with the delivery system and covered the visceral vessels.Dr.(b)(6) asked to have dr.(b)(6) come to the room.I pulled a graft out to put in dr.(b)(6) hands so he could feel the graft.He asked if it had active fixation and i answered it did not.Dr.(b)(6) then pulled the delivery system with the graft attached further back towards the groin in a slow manner uncovering the visceral vessels.He then performed a cutdown at the right femoral artery and pulled the graft out of the patient.The 22fr dry seal sheath was inserted and a power injection of contrast was performed to view the visceral vessels.The celiac was patent and slow flow was observed in the sma.Dr.(b)(6) then attempted an endovascular approach to wire the sma in order to stent.He could not get the sma cannulated with the wire and decided to do an open procedure to put the wire in the sma by hand.Once the wire was in the sma an i-cast, 7 x 22 was placed in the sma at the ostium.Next, the doctor performed an aorta bifemoral." patient outcome: "patient had excessive swelling in their abdominal cavity after the aorta bifemoral bypass.Will go back to the or on (b)(6) after the swelling has subsided for closure of the incision on his abdomen.The doctors told me this is common on obese patients.".

Manufacturer Narrative

Attachment: [(initial report) follow-up evaluation.Pdf].

Event Description

"dissection (type b) of the descending aorta.The relay plus thoracic graft, 36/32 x 250, lot # 171228127, was introduced into the right femoral artery and advanced 4/5cm above the celiac artery.The grey deployment grip was pushed forward and the secondary sheath with the graft was advanced to the lsa.Before moving to step 2 on the controller.It was pointed out that the grey deployment handle was not up to the black line.The doctor then held the grey deployment knob still while pulling back the black fixed grip until the black line was crossed.The controller was then changed to the 2 position and the doctor exposed the first covered graft segment by sliding the grey deployment grip back.The doctor hand position: right hand on the red mental around 2 inches behind grey deployment grip.Left hand on the grey deployment grip.While under fluoro the left hand slid the grey deployment grip till hits his right hand thus exposing the first covered segment.Fluoro was on while final position of the graft was achieved.Happy with the position of the graft the doctor then slid the grey handle with a frim and rapid motion until the grey grip would not move distal any further.Number 3 on the deployment device was next performed by removing the screw and white retainer and sliding the #3 knob distal back towards the wire hub.The proximal clasp released the graft without any issue.#4 on the controller was next moved into position and the stainless steel was gripped and pulled back, moving the nose cone back into the primary sheath.The doctor asked for a 22fr dry seal sheath and i pointed to where the sheath was while the doctor pulled back on the delivery system to remove.The graft moved with the delivery system and covered the visceral vessels.Dr.(b)(6) asked to have dr.(b)(6) come to the room.I pulled a graft out to put in dr.(b)(6) hands, so he could feel the graft.He asked if it had active fixation and i answered it did not.Dr.(b)(6)then pulled the delivery system with the graft attached further back towards the groin in a slow manner uncovering the visceral vessels.He then performed a cutdown at the right femoral artery and pulled the graft out of the patient.The 22fr dry seal sheath was inserted and a power injection of contrast was performed to view the visceral vessels.The celiac was patent and slow flow was observed in the sma.Dr.(b)(6) then attempted an endovascular approach to wire the sma to stent.He could not get the sma cannulated with the wire and decided to do an open procedure to put the wire in the sma by hand.Once the wire was in the sma an i-cast, 7 x 22 was placed in the sma at the ostium.Next, the doctor performed an aorta bifemoral." patient outcome: "patient had excessive swelling in their abdominal cavity after the aorta bifemoral bypass.Will go back to the or on october 30 after the swelling has subsided for closure of the incision on his abdomen.The doctors told me this is common on obese patients.I will get an update later.Email update provided on 03/27/2019: patient is walking and talking and doing well.Just spoke to the doctor two weeks about him.".

• 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: 8103780
• MDR Text Key: 128570811
• Report Number: 2247858-2018-00172
• 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: 04/08/2019

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: 12/20/2021
• Device Catalogue Number: 28-M336250322490U
• Device Lot Number: 171228127
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR