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

Catalog Number 28-M334145302390U

Device Problems Retraction Problem (1536); Sticking (1597); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

During an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.

Event Description

Summary: the inner sheath was accidentally retracted while being advanced in the aortic arch.Description / sequence of events: (b)(6) 2017 -tevar for zone2 was performed with left subclavian artery to common carotid artery bypass grafting.-after bypass grafting procedure, 6fr sheath and a guidewire (lounderquist double-curved) was inserted into the right femoral artery for tevar.-the delivery system of this replyplus was then inserted as planned, and the inner sheath was advanced out from the outer sheath before reaching the aortic arch.-the inner sheath was then advanced further, and while passing the aortic arch, the inner sheath was confirmed to be retracted slightly and the first covered stent was deployed.Deployed stent on the greatest curvature side was stuck at the entry of left subclavian artery, and it became difficult to advance it further.-the bare stent was still fixed on the apex holder, so it was not deployed.Only the inner sheath was retracted.-during the procedure (when the inner sheath was advanced out from the outer sheath), its diameter looked bigger than usual, but it is unknown if the inner sheath was already retracted and the first covered stent was deployed at that point.In addition, when advancing the inner sheath, d-shaped maker on the inner sheath was found on more distal than usual.-there was some difficulty, but the inner sheath finally could be advanced until it reached the desired point, and the stentgraft was deployed under the left common carotid artery.-the procedure was completed without further problems.".

• 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: matthew stark ; 799 international parkway; sunrise, FL 33325 ; 8548389699
• MDR Report Key: 7325873
• MDR Text Key: 102195076
• Report Number: 2247858-2018-00079
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-M334145302390U
• Device Lot Number: 160719265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 81 YR