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

Catalog Number 28-M4-38-250-38U

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Foreign Body In Patient (2687); Skin Infection (4544)

Event Date 02/03/2024

Event Type  Injury  

Event Description

"rash on the right and left thighs: after a relayplus stent-graft was implanted, the landing zone on the distal side was shortened.On (b)(6) 2024, the relaypro stent-graft was therefore additionally implanted on the distal side.After a 22 fr dryseal sheath (gore) was placed, the stent-graft concerned was attempted to be inserted by passing through the sheath.The stent-graft was first attempted to be delivered using a lunderquist double curved stiff guidewire (cook medical), but the stent-graft failed to reach the intended position (proximal end: proximal descending aorta, distal end: slightly proximal to the origin of the celiac artery) due to the curvature of the descending aorta and frictional resistance of the implanted relaypro and was once removed from the patient.The stent-graft was then delivered to the intended position via pull-through technique.Using the lunderquist double curved stiff guidewire, the stent-graft was implanted at the target site.Post dilatation was performed at the junction, and the procedure was completed as angiography confirmed no endoleak.About 2 days after the procedure, a rash was noted on the right and left thighs.The rash on the right thigh was widespread, while one on the left thigh was mild.No treatment was given for the rash.The patient was followed up, and as of (b)(6) the rash disappeared.Surgeon's comments: the surgeon consulted a dermatologist.After the rash was biopsied and confirmed, foreign matter was found.It is thought that the foreign matter was spread to the peripheral bleed vessels, which resulted in the rash due to poor circulation.The surgeon requested an investigation to determine whether the foreign matter was from some of terumo's products, such as the stent-graft, radifocus guidewires, and an introducer sheath.Operation type: tevar.No blood loss.Ancillary devices used: introducer sheath, radifocus guidewire (0.035), radifocus half-stiff guidewire (0.035), snare catheter, angiographic catheter.Image available (see the attached 2 images) pre-case plan available: see the attached schema.Additional information will be able to be obtained.(tc#(b)(4))".Patient outcome: "the patient's condition is favorable.".

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

"rash on the right and left thighs: after a relayplus stent-graft was implanted, the landing zone on the distal side was shortened.On (b)(6) 2024, the relaypro stent-graft was therefore additionally implanted on the distal side.After a 22 fr dryseal sheath (gore) was placed, the stent-graft concerned was attempted to be inserted by passing through the sheath.The stent-graft was first attempted to be delivered using a lunderquist double curved stiff guidewire (cook medical), but the stent-graft failed to reach the intended position (proximal end: proximal descending aorta, distal end: slightly proximal to the origin of the celiac artery) due to the curvature of the descending aorta and frictional resistance of the implanted relaypro and was once removed from the patient.The stent-graft was then delivered to the intended position via pull-through technique.Using the lunderquist double curved stiff guidewire, the stent-graft was implanted at the target site.Post dilatation was performed at the junction, and the procedure was completed as angiography confirmed no endoleak.About 2 days after the procedure, a rash was noted on the right and left thighs.The rash on the right thigh was widespread, while one on the left thigh was mild.No treatment was given for the rash.The patient was followed up, and as of (b)(6) 2024 the rash disappeared.Surgeon's comments: the surgeon consulted a dermatologist.After the rash was biopsied and confirmed, foreign matter was found.It is thought that the foreign matter was spread to the peripheral bleed vessels, which resulted in the rash due to poor circulation.The surgeon requested an investigation to determine whether the foreign matter was from some of terumo's products, such as the stent-graft, radifocus guidewires, and an introducer sheath.Operation type: tevar no blood loss.Ancillary devices used: introducer sheath, radifocus guidewire (0.035), radifocus half-stiff guidewire (0.035), snare catheter, angiographic catheter.Image available.Pre-case plan available: see the attached schema.Additional information will be able to be obtained.(tc#(b)(4))".Patient outcome: "the patient's condition is favorable.".

• Brand Name: RELAY PRO 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: 18865497
• MDR Text Key: 337207442
• Report Number: 2247858-2024-00059
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/22/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-M4-38-250-38U
• Device Lot Number: 2302140198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• 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): Other