MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation, a follow up report will be submitted.Associated file: mdr 1219977-2015-00303.

Event Description

It was reported that a covered stent was advanced into the renal artery and was too long and had to be switched out.

Manufacturer Narrative

No product or lot numbers were provided.The product was not returned.Information obtained from the physician that this was not a product failure, but an operative fault in selecting the incorrect size for the target lesion.Special care should be taken to ensure that the appropriate size devices are selected prior to introduction is stated in the instructions for use.Excessive stent length increases the chance of late loss down the road, and stenting too short means you miss the edge of the lesion and increase the patient's chances of repeat revascularization.An elective procedure should include an accurate measurement to put the right-sized stent in the right place and reduce the patient's chances of coming back.The use of intravascular ultrasound or computed tomography should ideally be used in every hemodynamically stable case.The instructions for use state, "native lumen dimensions must be accurately measured, not estimated.'.

• Brand Name: ATRIUM ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5150507
• MDR Text Key: 28303830
• Report Number: 1219977-2015-00304
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• 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