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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-B2-33-100U
Device Problems Detachment of Device or Device Component (2907); Ejection Problem (4009)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/15/2002
Event Type  Death  
Manufacturer Narrative
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.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
"the physician needed to modify the treo to fit the anatomy.The graft was placed above the celiac with fenestrations made for the celiac, sma, and right renal (the left renal was occluded prior to the start of the case).The physician had placed the graft over a guidewire advantage wire and was manipulating it over that wire.When the physician was ready to deploy the proximal clasp, he did so in the regular fashion by pushing in and twisting the grey and pulling back on the black piece.There was no translation of movement to the proximal end of the catheter and the clasp did not move.He then expanded the hypotube to better expose and access the green catheter.That was cut longitudinally, and he tried to retract that way.He applied significant force to the green tube and eventually the proximal clasp holder mechanism on the very distal portion of the catheter broke off.He continued pulling and pushing on the green tube and the device.He tried snaring the tip of the nosecone from the arm to get traction on the nosecone while pulling on the green tube.It simply would not release.Ultimately the patient underwent a thoracotomy to remove the nosecone.This was successful and the graft was left in place." patient outcome - "the patient was sent to the icu for monitoring after the case.Pod 2 the patient expired from micro emboli to the bowel.".
 
Manufacturer Narrative
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.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
"the physician needed to modify the treo to fit the anatomy.The graft was placed above the celiac with fenestrations made for the celiac, sma, and right renal (the left renal was occluded prior to the start of the case).The physician had placed the graft over a guidewire advantage wire and was manipulating it over that wire.When the physician was ready to deploy the proximal clasp, he did so in the regular fashion by pushing in and twisting the grey and pulling back on the black piece.There was no translation of movement to the proximal end of the catheter and the clasp did not move.He then expanded the hypotube to better expose and access the green catheter.That was cut longitudinally, and he tried to retract that way.He applied significant force to the green tube and eventually the proximal clasp holder mechanism on the very distal portion of the catheter broke off.He continued pulling and pushing on the green tube and the device.He tried snaring the tip of the nosecone from the arm to get traction on the nosecone while pulling on the green tube.It simply would not release.Ultimately the patient underwent a thoracotomy to remove the nosecone.This was successful and the graft was left in place." patient outcome - "the patient was sent to the icu for monitoring after the case.Pod 2 the patient expired from micro emboli to the bowel.".
 
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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 Key17261416
MDR Text Key318437058
Report Number2247858-2023-00184
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P190015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/28/2023
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 Date11/04/2023
Device Catalogue Number28-B2-33-100U
Device Lot Number2009220350
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2023
Initial Date FDA Received07/05/2023
Supplement Dates Manufacturer Received06/19/2023
Supplement Dates FDA Received08/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age78 YR
Patient SexFemale
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