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

Model Number 85329

Device Problems Burst Container or Vessel (1074); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation, a follow up report will be submitted.

Event Description

During an endovascular procedure of abdominal aortic endoprosthesis, the balloon burst at 4 atm and the covered stent did not deploy.No clinical consequences were reported.The patient is in good condition.

Manufacturer Narrative

Engineering investigation: the returned device was disinfected and evaluated to determine the cause of the complaint.Upon inspection, the balloon had been only partially inflated in the proximal and distal balloon cones.To determine if the balloon was damaged it was pressurized.A leak was detected in the distal balloon cone.The damage was viewed at 20x magnification and was determined to be external damage and not a manufacturing defect.The hole was rather large and prohibited the balloon from opening.The introducer sheath used in the case was not returned.A full review of the catheter lot history records for the devices in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.This inspection requires that the catheter lot must pass the following: · ability of the stent and delivery system to be passed through the labeled introducer sheath.· ability to deploy the stent at nominal pressure (8atm).· ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.· ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.· balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.The lot history records also indicate that the lowest burst value seen out of over 40 samples tested was 18.9 atm.This is well above the rated burst pressure of 12 atm as listed on the product label.Manufacturing also 100% pressure tests every device to ensure there are no leaks anywhere in the catheter system.There is a possibility that the balloon was damaged during the procedure had the balloon made contact with the abdominal aortic endoprosthesis.Clinical evaluation: causes of balloon rupture include contact with the endovascular graft, the angle of the target and the disease state of the target.The instructions for use (ifu) state as a contraindication the use of the advanta v12 in non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation sufficiently to allow passage of the delivery catheter.A stent can become dislodged if the vessel has calcification or severe disease, if the vessel has not been properly pre-dilated, if the stent has not been sized correctly or if the physician uses force to advance or withdraw the catheter.The ifu states potential adverse effects include, but may not be limited to inadequate implantation or intimal trauma and stent misplacement, migration or deformity.It also warns to not force passage or withdrawal of the guidewire or delivery system if resistance is encountered and to not attempt to reposition a fully or partially expanded stent.

• Brand Name: ATRIUM ADVANTA V12
• 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 rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6414419
• MDR Text Key: 70247575
• Report Number: 1219977-2017-00026
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: 85329
• Device Catalogue Number: 85329
• Device Lot Number: 244559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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
• Patient Age: 85 YR