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

Catalog Number 28-M344155442590U

Device Problems Product Quality Problem (1506); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  Injury  

Event Description

Inner-sheath was torn during the operation.[description / sequence of events] on (b)(6) 2017: - 1-debranching operation was performed first, and then tevar was started for thoracic aorta aneurysm.- relayplus was inserted from the right femoral artery, and outer-sheath was advanced.- the pigtail catheter was inserted from the left femoral artery and advanced to the proximal portion of aneurysm.Angiogram was performed.- relayplus inner-sheath was then advanced out from the outer-sheath, and then it was advanced to the intended position (zone2).With the controller in "2" position, 1.5 stent was exposed by retracting the inner-sheath.- angiogram was performed again with the pigtail in the same position.The physician then attempted to remove the pigtail after the angiogram; however, the pigtail got stuck at the tip of stent graft.When the pigtail was pulled, the inner-sheath was torn and the rest of stent graft was deployed as a result (see pictures below).(the expansion force of already deployed 1.5 stent graft could possibly apply any stress to the inner-sheath, leading to tearing the sheath.The sheath was less likely to be torn by an interference with pigtail itself).- the pigtail was removed after stent graft deployment.- the inner-sheath was then completely retracted in controller "2" position, and then the bare stent was released in controller "3" position.- in controller "4"position, the delivery system was removed from the body.- angiogram was performed again to check the stent graft position, and no endoleak was confirmed.- lsa was occluded with the coil and whole operation was completed.- physician's comment: please investigate the reason of inner-sheath tear, as well as inner-sheath durability quality." patient outcome: "tevar was completed without any adverse event on the patient.".

Event Description

"[summary] inner-sheath was torn during the operation [description / sequence of events]: (b)(6) 2017: 1-debranching operation was performed first, and then tevar was started for thoracic aorta aneurysm.Relayplus was inserted from the right femoral artery, and outer-sheath was advanced.The pigtail catheter was inserted from the left femoral artery and advanced to the proximal portion of aneurysm.Angiogram was performed.Relayplus inner-sheath was then advanced out from the outer-sheath, and then it was advanced to the intended position (zone2).With the controller in "2" position, 1.5 stent was exposed by retracting the inner-sheath.Angiogram was performed again with the pigtail in the same position.The physician then attempted to remove the pigtail after the angiogram; however, the pigtail got stuck at the tip of stentgraft.When the pigtail was pulled, the inner-sheath was torn and the rest of stentgraft was deployed as a result.(the expansion force of already deployed 1.5 stentgraft could possibly apply any stress to the inner-sheath, leading to tearing the sheath.The sheath was less likely to be torn by an interference with pigtail itself).The pigtail was removed after stentgraft deployment.The inner-sheath was then completely retracted in controller "2" position, and then the bare stent was released in controller "3" position.In controller "4"position, the delivery system was removed from the body.Angiogram was performed again to check the stentgraft position, and no endoleak was confirmed.Lsa was occluded with the coil and whole operation was completed.Physician's comment: please investigate the reason of inner-sheath tear, as well as inner-sheath durability quality." patient outcome: "tevar was completed without any adverse event on the patient.".

• 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
• MDR Report Key: 7095514
• MDR Text Key: 94132509
• Report Number: 2247858-2017-00025
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2018
• Device Catalogue Number: 28-M344155442590U
• Device Lot Number: 150505029
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR