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

Catalog Number 28-M4-34-200-34U

Device Problems Device Slipped (1584); Difficult or Delayed Separation (4044)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

This complaint is being reported past the timeline requirement due to a clerical error made where the reportability decision was incorrectly identified as non-reportable within an internal tracking system.As of the date of this report, there have been no additional late reports.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

"after steps 1 and 2 on the device, we were unable to release the proximal bare springs of the 34x200 bare metal device for about 1-2 minutes which in turn we most distal (away from our target landing zone) by about 8mm.While i was explain to dr kindzelski how we were going to release the device, he tried one more time and it did release easily.After it release we noticed the ~8mm target miss distally.We were able to plug the lsa with a amplatzer ii plug after the second relay pro was delivered.No harm to the pt and physicians ((b)(6)) we ultimately happy with the procedure.I followed up with both physicians this morning ((b)(6) 2023) and the pt is doing well.Set to have the spinal drain removed today ((b)(6) 2023) repeat scan prior to discharge.Follow up with physicans by end of the week." patient outcome: "goal reached of fixing sub-acute dissection and lsa plug.No harm to the pt.".

Event Description

"after steps 1 and 2 on the device, we were unable to release the proximal bare springs of the 34x200 bare metal device for about 1-2 minutes which in turn we most distal (away from our target landing zone) by about 8mm.While i was explain to dr (b)(6) how we were going to release the device, he tried one more time and it did release easily.After it release we noticed the ~8mm target miss distally.We were able to plug the lsa with a amplatzer ii plug after the second relay pro was delivered.No harm to the pt and physicians (b)(6) we ultimately happy with the procedure.I followed up with both physicians this morning (8-8-23) and the pt is doing well.Set to have the spinal drain removed today (8-8-23) repeat scan prior to discharge.Follow up with physicans by end of the week." patient outcome: "goal reached of fixing sub-acute dissection and lsa plug.No harm to the pt.".

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.

• 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: 17926426
• MDR Text Key: 326133133
• Report Number: 2247858-2023-00252
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-M4-34-200-34U
• Device Lot Number: 2302010149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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: 70 YR
• Patient Sex: Male