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

Catalog Number 28-M334145342390U

Device Problems Burst Container or Vessel (1074); Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 03/27/2018

Event Type  Death  

Event Description

"physician advanced the device into the anatomy and proceeded successfully with step 1, step2 and step 3.When he went to step 4, he turned the dial from 2 to 4 and began to retract the stainless steel rod.The nose cone got hung up at the distal end of the graft.Upon closer view, it appeared the most distal stent ring was compressed in the aorta, thus not allowing the nosecone to pass by and the device to remove from the anatomy.After rotating the steel rod clockwise and counter clockwise several times, we considered getting arm access and sending a balloon down from the arm to expand the distal stent ring.While considering this, the physician employed more tension on the steel rod to the point where the nose cone separated from the delivery system.The delivery system was able to be removed, but the nosecone remained lodged inside the graft, as the compressed distal stent ring kept the nosecone from traveling distal.We noticed on fluoro that both the celiac and sma were now covered due to the pulling distal of the delivery system.The physician sent a 6mm x 20mm balloon, then a 8mm x 20mm balloon up the ipsi wire to inflate and open up the distal portion of the stent graft.Both balloons popped before getting to nominal, thus failing.At this point, the physician lost ipsi wire access.A decision was made by the physician to convert to an open procedure.He performed an axial:femoral bypass to allow for distal perfusion.All pertinent vessels (celiac, sma, renals) were now perfused due to this bypass.He is planning to send this patient to (b)(6) today for a type 4 thoraco abdominal open procedure." below is the update received on the patient (email dated (b)(6) 2018): "dr.(b)(6) performed an axial - fem bypass and then transferred her to (b)(6).This occurred on tuesday.On wednesday, it is my understanding that dr.(b)(6) performed an open repair and noticed the distal end of the stent was not expanded.She cut the distal portion of the graft and sewed the remaining section to the aortic wall.Unfortunately, the patient had a massive stroke and the family elected to remove her from life support.".

Manufacturer Narrative

[(b)(4)].

Event Description

"physician advanced the device into the anatomy and proceeded successfully with step 1, step2 and step 3.When he went to step 4, he turned the dial from 2 to 4 and began to retract the stainless steel rod.The nose cone got hung up at the distal end of the graft.Upon closer view, it appeared the most distal stent ring was compressed in the aorta, thus not allowing the nosecone to pass by and the device to remove from the anatomy.After rotating the steel rod clockwise and counter clockwise several times, we considered getting arm access and sending a balloon down from the arm to expand the distal stent ring.While considering this, the physician employed more tension on the steel rod to the point where the nose cone separated from the delivery system.The delivery system was able to be removed, but the nosecone remained lodged inside the graft, as the compressed distal stent ring kept the nosecone from traveling distal.We noticed on fluoro that both the celiac and sma were now covered due to the pulling distal of the delivery system.The physician sent a 6mm x 20mm balloon, then a 8mm x 20mm balloon up the ipsi wire to inflate and open up the distal portion of the stent graft.Both balloons popped before getting to nominal, thus failing.At this point, the physician lost ipsi wire access.A decision was made by the physician to convert to an open procedure.He performed an axial:femoral bypass to allow for distal perfusion.All pertinent vessels (celiac, sma, renals) were now perfused due to this bypass.He is planning to send this patient to (b)(6) today for a type 4 thoraco abdominal open procedure." below is the update received on the patient (email dated (b)(6) 2018): "dr.(b)(6) performed an axial - fem bypass and then transferred her to (b)(6).This occurred on tuesday.On wednesday, it is my understanding that dr.(b)(6) performed an open repair and noticed the distal end of the stent was not expanded.She cut the distal portion of the graft and sewed the remaining section to the aortic wall.Unfortunately, the patient had a massive stroke and the family elected to remove her from life support.".

• 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: 7456621
• MDR Text Key: 106381807
• Report Number: 2247858-2018-00129
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Catalogue Number: 28-M334145342390U
• Device Lot Number: 170504210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2017
• 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): Death; Required Intervention
• Patient Age: 82 YR