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

Catalog Number 28-BC33B14014S1960

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6) hospital is voluntarily reporting an event related to a treo custom made device.Custom made treo devices are not marketed in the us, however they are similar to the treo abdominal stent graft system approved for sale in the us (p190015).The event occurred in germany.(b)(6) hospital, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

"intraop after placement from the graft and stented sma+coe.After that both renal fens are much to high.(mr.B)(6) pull with a pta-ballon in the dockingzone massiv the graft down.It was hard and critical to move both renal stents in the renals.We miss about 1 cm length between sma + rra/lra fens.At the end we checked with a pigtail with markers.The device documents show 95mm between top of the graft and the device shows 85mm between this.Long time risk: all little renal stents are under strong tension now.So the risk for a complication postoperative in month or years is much higher now.We just like to give feedback! " patient outcome: "good, stabil, well.".

Event Description

"intraop after placement from the graft and stented sma+coe.After that both renal fens are much to high.Mr elger pull with a pta-ballon in the dockingzone massiv the graft down.It was hard and critical to move both renal stents in the renals.We miss about 1 cm length between sma + rra/lra fens.At the end we checked with a pigtail with markers.The device documents show 95mm between top of the graft and the device shows 85mm between this.Long time risk: all little renal stents are under strong tension now.So the risk for a complication postoperative in month or years is much higher now.We just like to give feedback! " patient outcome: "good, stable, well.".

Manufacturer Narrative

Bolton medical inadvertently reported this complaint under mdr 2247858-2024-00045.However, this complaint is not reportable since it is related to a custom-made fenestrated treo device.Based on the nature of this complaint, the subject device is not considered similar to the us approved treo product family (p190015).Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 18627549
• MDR Text Key: 335219604
• Report Number: 2247858-2024-00045
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-BC33B14014S1960
• Device Lot Number: 2311280269
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2024
• 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): Other
• Patient Age: 78 YR
• Patient Sex: Male