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

Catalog Number 28-L2-15-160U

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

After deployment of treo bifurcate device from delivery system, delivery system was retracted, and tip along with approximately 7 cm of hypotube remained on wire inside patient.Tip/hypotube was subsequently snared with "gooseneck" snare and removed.Treo 15 x 160 limb was deployed in the standard fashion, with rotation of the gray handle.After approximately 3 stents were deployed, the gray handle rotated without moving at all along the black "teeth" of the mechanical advantage (so gray handle was rotating "in place", and not moving longitudinally), and no further deployment of treo limb was possible.Physician subsequently pulled on gray handle while holding black treo grip, and device, with much resistance, was deployed.Patient outcome - "no injury to patient; no further evolution, nor treatment.".

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr-2247858-2022-00064.

Manufacturer Narrative

This complaint was involved with two devices.Device 1 is being reported under mdr-2247858-2022-00064 and device 2 is being reported under mdr-2247858-2022-00065.

Event Description

After deployment of treo bifurcate device from delivery system, delivery system was retracted, and tip along with approximately 7 cm of hypotube remained on wire inside patient.Tip/hypotube was subsequently snared with "gooseneck" snare and removed.Treo 15 x 160 limb was deployed in the standard fashion, with rotation of the gray handle.After approximately 3 stents were deployed, the gray handle rotated without moving at all along the black "teeth" of the mechanical advantage (so gray handle was rotating "in place", and not moving longitudinally), and no further deployment of treo limb was possible.Physician subsequently pulled on gray handle while holding black treo grip, and device, with much resistance, was deployed.Patient outcome - "no injury to patient; no further evolution, nor treatment.".

• 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: 14146012
• MDR Text Key: 289668491
• Report Number: 2247858-2022-00065
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-L2-15-160U
• Device Lot Number: 2112130165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• 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 Age: 68 YR
• Patient Sex: Male