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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCUALR GRAFT, AORTIC
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BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCUALR GRAFT, AORTIC Back to Search Results
Catalog Number 28-M332095322290U
Device Problems Difficult to Remove (1528); Failure to Align (2522); Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2020
Event Type  malfunction  
Event Description
"deployment of graft was completed.Inner sheath and nose cone were reunited.The device controller was placed in position 2 when the delivery system was safely in the descending aorta.Difficulty removing the device from the access/per close site was experienced.When we looked at the controller- it was floating and would not seat into position 2 anymore.The tip of the device was just not coming out easily and was going to require force to pull it out.Surgeon decided to do a cut down.At that time it was noticed that the per close was placed at the level of the internal artery.The iliac artery was very tortuous and the surgeon had to repair the high stick.The surgeon believes the placement of the per close at the level of the internal combined with the tortuosity of the vessel were causing the device removal issue." patient outcome: "after patient received a mini groin cut-down, the device came out easily.The per close sutures were removed and groin was repaired.Patient went to holding and did well.".
 
Event Description
"deployment of graft was completed.Inner sheath and nose cone were reunited.The device controller was placed in position 2 when the delivery system was safely in the descending aorta.Difficulty removing the device from the access/per close site was experienced.When we looked at the controller- it was floating and would not seat into position 2 anymore.The tip of the device was just not coming out easily and was going to require force to pull it out.Surgeon decided to do a cut down.At that time it was noticed that the per close was placed at the level of the internal artery.The iliac artery was very tortuous and the surgeon had to repair the high stick.The surgeon believes the placement of the per close at the level of the internal combined with the tortuosity of the vessel were causing the device removal issue." patient outcome: "after patient received a mini groin cut-down, the device came out easily.The per close sutures were removed and groin was repaired.Patient went to holding and did well.".
 
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Brand Name
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Type of Device
STENT, ENDOVASCUALR GRAFT, AORTIC
Manufacturer (Section D)
BOLTON MEDICAL, INC.
799 international parkway
sunrise FL 33325
MDR Report Key10217649
MDR Text Key200695159
Report Number2247858-2020-00031
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
PMA/PMN Number
P110038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/19/2023
Device Catalogue Number28-M332095322290U
Device Lot Number1910110051
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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