MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-N4-36-199-36S

Device Problems Separation Failure (2547); Difficult to Advance (2920); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Stenosis (2263); Insufficient Information (4580)

Event Date 08/08/2023

Event Type  Death  

Event Description

"after performing of bypass lca-lsa clinician prepared for endovascular procedure with a lunderquist guidewire from right side and pig tail from the left; after angiogram he advanced relay pro nbs as usual: position the outer sheath into thoracic aorta below the isthmus and step 1:holding the grey grip and rotate the deployment grip clockwise until the white arrow on ds), step 2: he delivered the device with a pull back, step 3: rotate the apex holder and retracted as usual, under fluoroscopy he noticed the clasping system was already in place.At this point: 1) he verified the apex holder was completely retracted and it did.2) he advanced the apex holder to redo step 3, but nothing happened.3) he tries to pull back the apex holder and, in the mean while in step 4, advance a few with stainless steel rod, but nothing happened (this maneuver was performed with (b)(6) in video call).4) he cut the apex holder and stainless-steel rod at that level in order to retract the green tube connect to the clasping in order to retract it, but nothing happen (this maneuver was performed with (b)(6) in video call).5) he tried to inflate a balloon into stent graft and advance in step 4 with stainless steel rod to disconnect the clasping, but nothing happened.6) he inserted a 8 fr introductory near the clasping and counterpull the entire system in order to release the clasping system, but nothing happen; after half an hour of attempts he decided to have a consultation with cardiac surgeon, and they decided to perform the sternotomy and remove the device.During the cardiac surgery, in circulation stop and moderate hypothermia, they noticed the green tube was not connected to the clasping system and the try with a klemmer to pull down the clasping but was impossible because it looks like was stuck to the tip structure (as glued or something like that as fixed).They cut the first nbs stent and remove it all from below." patient outcome - "still in icu in critical condition.Email dated 08/12/2023: patient passed away".

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

"after performing of bypass lca-lsa clinician prepared for endovascular procedure with a lunderquist guidewire from right side and pig tail from the left; after angiogram he advanced relay pro nbs as usual: position the outer sheath into thoracic aorta below the isthmus and step 1:holding the grey grip and rotate the deployment grip clockwise until the white arrow on ds), step 2: he delivered the device with a pull back, step 3: rotate the apex holder and retracted as usual, under fluoroscopy he noticed the clasping system was already in place.At this point: 1) he verified the apex holder was completely retracted and it did.2) he advanced the apex holder to redo step 3, but nothing happened.3) he tries to pull back the apex holder and, in the mean while in step 4, advance a few with stainless steel rod, but nothing happened (this maneuver was performed with alberto donina in video call) 4) he cut the apex holder and stainless-steel rod at that level in order to retract the green tube connect to the clasping in order to retract it, but nothing happen (this maneuver was performed with alberto donina in video call) 5) he tried to inflate a balloon into stent graft and advance in step 4 with stainless steel rod to disconnect the clasping, but nothing happened.6) he inserted a 8 fr introductory near the clasping and counterpull the entire system in order to release the clasping system, but nothing happen; after half an hour of attempts he decided to have a consultation with cardiac surgeon, and they decided to perform the sternotomy and remove the device.During the cardiac surgery, in circulation stop and moderate hypothermia, they noticed the green tube was not connected to the clasping system and the try with a klemmer to pull down the clasping but was impossible because it looks like was stuck to the tip structure (as glued or something like that as fixed).They cut the first nbs stent and remove it all from below.This form was sent 10/08 because, since i was not in or, i wait the meeting with clinician to communicate the step of the intervention did on 08/08.The clinician give us an appointment today (b)(6)." patient outcome: "still in icu in critical condition.Email dated (b)(6) 2023: "patient passed away.".

• Brand Name: RELAY PRO NBS THORACIC STENT-GRAFT 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: 17663449
• MDR Text Key: 322423158
• Report Number: 2247858-2023-00219
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N4-36-199-36S
• Device Lot Number: B230321189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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
• Patient Age: 99 YR