MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-M4-40-250-36U

Device Problems Mechanical Problem (1384); Ejection Problem (4009)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

"dr.(b)(6) was deploying a relaypro 28-m4-40-250-36u in zone 3 distal to the lsa.He performed steps 1 and 2 per the ifu in the proper fashion.During step 3 the proximal clasp did not release the bare stent when the apex release grip was moved caudally.(b)(6) (ta) instructed dr.(b)(6) to attempt turning the apex release grip 180 degrees and redeploy.That maneuver did not release the bare stent.(b)(6) instructed dr.(b)(6) to attempt to straighten the delivery system by pulling the lunderquist wire back so the floppy portion was close to the tip.That did not help.(b)(6) then instructed dr.(b)(6) to use a mosquito tip clamp to spread the gap in the stainless steel rod exposing the green outer tube.(b)(6) (ta) supported on facetime instructing dr.(b)(6) to cut the green tube with an 11 blade exposing the wire.The wire was clamped and pulled caudally several times with extreme force to release the clasp.During the manipulation of the delivery system, the lunderquist wire was bent.The delivery system could not be removed over the wire.The wire was removed from the system with some effort and a glidewire was inserted into the delivery system and step 4 was performed and the delivery system was removed and replaced with a 18f dryseal." patient outcome - "a 36x100 relayplus was placed as a distal extension and the case was completed successfully eliminating the aneurysm.".

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

"(b)(6) was deploying a relaypro 28-m4-40-250-36u in zone 3 distal to the lsa.He performed steps 1 and 2 per the ifu in the proper fashion.During step 3 the proximal clasp did not release the bare stent when the apex release grip was moved caudally.Craig small (ta) instructed dr.Selim to attempt turning the apex release grip 180 degrees and redeploy.That maneuver did not release the bare stent.Craig instructed dr.Selim to attempt to straighten the delivery system by pulling the lunderquist wire back so the floppy portion was close to the tip.That did not help.Craig then instructed dr.Selim to use a mosquito tip clamp to spread the gap in the stainless steel rod exposing the green outer tube.Chris kirupaharan (ta) supported on facetime instructing dr.Selim to cut the green tube with an 11 blade exposing the wire.The wire was clamped and pulled caudally several times with extreme force to release the clasp.During the manipulation of the delivery system, the lunderquist wire was bent.The delivery system could not be removed over the wire.The wire was removed from the system with some effort and a glidewire was inserted into the delivery system and step 4 was performed and the delivery system was removed and replaced with a 18f dryseal." patient outcome - "a 36x100 relayplus was placed as a distal extension and the case was completed successfully eliminating the aneurysm.".

• Brand Name: RELAY PRO THORACIC 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: 17097233
• MDR Text Key: 317831778
• Report Number: 2247858-2023-00143
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200045
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Catalogue Number: 28-M4-40-250-36U
• Device Lot Number: 2109150044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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: 69 YR
• Patient Sex: Male