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

Catalog Number 28-L2-17-080S

Device Problems Fluid/Blood Leak (1250); Material Invagination (1336)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

"device: treo, catalogue number: pending.Surgeon: (b)(6).Implant date: (b)(6) 2022.Description of event: kinking of stent with suspected moderate stenosis at left a.Iliaca adverse event start date:(b)(6) 2022.Was the adverse event serious? yes.Related to procedure: related.Related to device: related to iliac leg.Anticipated/unanticipated event: anticipated.Adverse even outcome: reimplantation of a new stent graft (details for reintervention) recovered - apr 2022".Patient outcome - "after the procedure a type ii endoleak was observed (right iliac).Was resolved by balloon angioplasty.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00083, and device 3 is being reported under mdr-2247858-2022-00085.

Event Description

"device: treo catalogue number: pending - see image below surgeon: (b)(6) implant date: (b)(6) 2022 description of event: kinking of stent with suspected moderate stenosis at left a.Iliaca adverse event start date: (b)(6) 2022 was the adverse event serious? yes related to procedure: related related to device: related to iliac leg anticipated/unanticipated event: anticipated adverse even outcome: reimplantation of a new stent graft (details attached for reintervention) recovered (b)(6) 2022" patient outcome - "after the procedure a type ii endoleak was observed (right iliac).Was resolved by balloon angioplasty.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00083, device 2 is being reported under mdr-2247858-2022-00084, and device 3 is being reported under mdr-2247858-2022-00085.

• 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: 14605185
• MDR Text Key: 301751126
• Report Number: 2247858-2022-00084
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2023
• Device Catalogue Number: 28-L2-17-080S
• Device Lot Number: B200115340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2020
• 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 Age: 74 YR
• Patient Sex: Male