MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC HERO ARTERIAL GRAFT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number HERO1002

Device Problems Kinked (1339); Material Separation (1562)

Patient Problems Failure of Implant (1924); Thrombosis (2100)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

The implant is functioning after the revision and is not expected to return for evaluation.A review of the complaint database showed no related reports for this lot.

Event Description

The account reported that the implant kinked inside the patient resulting in part of the implant disconnecting from the graft.The physician performed a thrombectomy and fixed the separation of the device.The device is still implanted and functioning without problems.

Manufacturer Narrative

No device is expected to be returned for evaluation.Because the unit was not returned, a formal investigation of the affected device could not be completed and the root cause could not be determined.If the device is returned in the future, this investigation will be reopened and a follow up submitted.The device history record was reviewed and no exception documents were found.

• Brand Name: HERO ARTERIAL GRAFT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5523597
• MDR Text Key: 41339132
• Report Number: 1721504-2016-00037
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HERO1002
• Device Lot Number: H15AV011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention