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

Catalog Number 28-M334200302490U

Device Problems Failure to Align (2522); Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr 2247858-2018-00160.Device 2 is being reported under mdr 2247858-2018-00161.

Event Description

"procedure: zone 1 tevar - endleak (type i): after two debranching was performed, the proximal side relay plus (28-m3 34) device was deployed under the brachiocephalic aneurysm.However, the lesser curvature side of the center of the relay plus device was slightly misaligned and its pressure joining was not securely achieved and type 1 endleak was observed.The distal side relay plus (28-m3 36) device was positioned in the location where slightly closer to the center than the proximal side relay plus device.Type 1 endleak disappeared and the procedure was successfully completed.On (b)(6) 2018: when the patient was checked, it was noted that the aneurysm enlarged after it had contracted once.Type 1a endleak to the aneurysm was also observed by cta.On (b)(6) 2018: both the proximal and distal sides relay plus devices were migrated by 4 to 5 mm, but both devices on the center neck.In early cta, no leak was observed.In delay cta, a leak was observed from around the left subclavian artery (lsa) in which coils were deployed.Patient outcome: "on (b)(6) 2018: (b)(6) informed (b)(6) that a coil embolization procedure was performed because type ii endleak was found.".

• 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: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 7919696
• MDR Text Key: 122162891
• Report Number: 2247858-2018-00160
• 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: 09/28/2018

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 Expiration Date: 11/08/2018
• Device Catalogue Number: 28-M334200302490U
• Device Lot Number: 151110189
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR