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

Catalog Number 28-M342150422590U

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

The mdr assessment for this complaint was completed on time.However, due to internal miscommunication, the emdr was not filed within the 30 day timeframe.Bolton will enact steps to ensure this is a unique instance.

Event Description

"device was introduced via left iliac after ivus was performed.Lot # 161117104 was advanced over.035 " dc lunderquist via left femoral artery.The relay plus 42x150 was not able to pass through the existing aaa endograft left iliac limb for an undetermined reason.Physicians attributed this to either small lip on outer sheath was catching distal iliac limb fabric or the existing disease in the iliac limb prevented the delivery system from passing through the iliac artery.Delivery system was removed from patient after failure to navigate iliac.Angioplast was performed with derado angioplasty balloon.A 22 fr sheath was then passed through the iliac to ensure our delivery system had a diameter that would accommodate the 25 fr outer profile of our system.As lot # 161117104 was removed from patient a kink in the outer sheath was noticed.Lot # 161117104 was then passed over the dc lunderquist but would not pass through the iliac system.Physicians attributed this inability to navigate the iliac to the kink that occurred upon first delivery attempt.Delivery system was removed; a second 42x150 lot #161116237 was opened, prepped and navigated the patients anatomy without difficulty.The graft was placed just distal to left carotid artery as planned, and aneurysm was sealed.Patient was discharged on 3/16/18 in excellent condition and taa treated in completion.Lot # 161117104 was discarded before we could save the device for inspection." patient outcome: "the patient was treated with 42x150 lot # 161116237 successfully.Patient was discharged on (b)(6) 2018.".

Manufacturer Narrative

[mdr 2247858-2018-00130 follow-up evaluation.Pdf].

Event Description

"device was introduced via left iliac after ivus was performed.Lot # 161117104 was advanced over.035 " dc lunderquist via left femoral artery.The relay plus 42x150 was not able to pass through the existing aaa endograft left iliac limb for an undetermined reason.Physicians attributed this to either small lip on outer sheath was catching distal iliac limb fabric or the existing disease in the iliac limb prevented the delivery system from passing through the iliac artery.Delivery system was removed from patient after failure to navigate iliac.Angioplast was performed with derado angioplasty balloon.A 22 fr sheath was then passed through the iliac to ensure our delivery system had a diameter that would accommodate the 25 fr outer profile of our system.As lot # 161117104 was removed from patient a kink in the outer sheath was noticed.Lot # 161117104 was then passed over the dc lunderquist but would not pass through the iliac system.Physicians attributed this inability to navigate the iliac to the kink that occurred upon first delivery attempt.Delivery system was removed; a second 42x150 lot #161116237 was opened, prepped and navigated the patients anatomy without difficulty.The graft was placed just distal to left carotid artery as planned, and aneurysm was sealed.Patient was discharged on (b)(6) 2018 in excellent condition and taa treated in completion.Lot # 161117104 was discarded before we could save the device for inspection." patient outcome: "the patient was treated with 42x150 lot # 161116237 successfully.Patient was discharged on (b)(6) 2018.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• MDR Report Key: 7438098
• MDR Text Key: 106260027
• Report Number: 2247858-2018-00130
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Catalogue Number: 28-M342150422590U
• Device Lot Number: 161117104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR