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

Catalog Number 28-B2-24-080S

Device Problem Partial Blockage (1065)

Patient Problems Thromboembolism (2654); Ruptured Aneurysm (4436)

Event Date 06/22/2022

Event Type  Death  

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported, device 2 is being reported under mdr-2247858-2022-00120, and device 3 is being reported under mdr-2247858-2022-00121.

Event Description

Description of event: iliac bifurcation rupture: adverse event start date: (b)(6) 2022.Was the adverse event serious? yes.Related to procedure: related.Related to device: undetermined.Anticipated/unanticipated event: unanticipated.Adverse even outcome: recovered.Extra information: placements of stents from common iliac artery to external iliac artery.Description of event: micro embolization: adverse event start date: (b)(6) 2022.Was the adverse event serious? yes.Related to procedure: related.Related to device: undetermined.Anticipated/unanticipated event: unanticipated.Extra information: iliac extensions to the external iliac artery.Adverse even outcome: death.Patient outcome - "as in section above.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00119, device 2 is being reported under mdr-2247858-2022-00120, and device 3 is being reported under mdr-2247858-2022-00121.Corrected data: in section d4, in the initial report the lot number was reported as b21030105.The lot was reworked and a new lot number (2103010050) was generated for that lot.

Event Description

Description of event: iliac bifurcation rupture.Adverse event start date: (b)(6) 2022 was the adverse event serious? yes.Related to procedure: related.Related to device: undetermined.Anticipated/unanticipated event: unanticipated.Adverse even outcome: recovered.Extra information: placements of stents from common iliac artery to external iliac artery.Description of event: micro embolization.Adverse event start date: (b)(6) 2022.Was the adverse event serious? yes.Related to procedure: related.Related to device: undetermined.Anticipated/unanticipated event: unanticipated.Extra information: iliac extensions to the external iliac artery.Adverse even outcome: death.Patient outcome - "as in section above.".

• 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: 15273615
• MDR Text Key: 298371821
• Report Number: 2247858-2022-00119
• 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: 01/05/2023

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: 03/05/2024
• Device Catalogue Number: 28-B2-24-080S
• Device Lot Number: 2103010050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2021
• 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): Death; Required Intervention
• Patient Age: 99 YR