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

Catalog Number 28-NC48N20046S22690

Device Problem Material Invagination (1336)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relayplus custom made device.The relayplus custom made device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).The relayplus custom made related event occurred in (b)(6).

Event Description

"relay cm 2386 was placed at the position.Control-ct showed infolding of the first 30mm endoleak.Email received on (b)(6) 2020 from (b)(6): hi (b)(6), spoken with them today.Patient fine so far.They will balloon the area under circulatory arrest end of (b)(6)/beginning of (b)(6)." patient outcome: "patient status after the procedure was fine.".

Event Description

"relay cm 2386 was placed at the position.Control-ct showed infolding of the first 30mm.Endoleak.Email received on august 5, 2020 from thomas roeding: hi manuel, spoken with them today.Patient fine so far.They will balloon the area under circulatory arrest end of (b)(6)." patient outcome: "patient status after the procedure was fine.".

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relay custom made device.The relay custom made device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).The relay custom made related event occurred in germany.

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCUALR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise, fl
• MDR Report Key: 10437466
• MDR Text Key: 204583542
• Report Number: 2247858-2020-00038
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 05/29/2021
• Device Catalogue Number: 28-NC48N20046S22690
• Device Lot Number: 2005220079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR