MAUDE Adverse Event Report: BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-L2-24-120S

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250)

Patient Problems Pulmonary Embolism (1498); Tachycardia (2095); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00097, device 2 is being reported under mdr-2247858-2022-00098.

Event Description

During first evar attempt (directly after incision in right groin) pt.Had an unexpected tachycardia and ended into successful reanimation.Couple of weeks later again evar with extra pacing lead to be safe.Evar went well, with no problems.A small type ii endoleaks presented on the postop angio.Technically no problems.During postop surveillance patient had 4 embolic events (2 in each leg) and extensive blood analyses did not find anything special.Because of these events and more important the patent type ii endoleak on the postop cta explantation of the evar was performed.During explantation 1 or 2 major type ii endoleaks were noticed but also a leakage was seen through the anterior side of the ipsi limp of the main body (type 3 or 4).Explanted device is available for investigation.Patient outcome - "after open surgery patient encountered a pulmonary embolism.".

Event Description

During first evar attempt (directly after incision in right groin) pt.Had an unexpected tachycardia and ended into successful reanimation.Couple of weeks later again evar with extra pacing lead to be safe.Evar went well, with no problems.A small type ii endoleaks presented on the postop angio.Technically no problems.During postop surveillance patient had 4 embolic events (2 in each leg) and extensive blood analyses did not find anything special.Because of these events and more important the patent type ii endoleak on the postop cta explantation of the evar was performed.During explantation 1 or 2 major type ii endoleaks were noticed but also a leakage was seen through the anterior side of the ipsi limp of the main body (type 3 or 4).Explanted device is available for investigation.Patient outcome - "after open surgery patient encountered a pulmonary embolism.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00097, device 2 is being reported under mdr-2247858-2022-00098, and device 3 is being reported under mdr-2247858-2022-00099.

• Brand Name: TREO ABDOMINAL 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: 14857860
• MDR Text Key: 295065107
• Report Number: 2247858-2022-00099
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P190015
• 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: 09/01/2022

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-L2-24-120S
• Device Lot Number: B200506256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male