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

Model Number 85330

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

Patient Problem No Information (3190)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During use of the product the balloon burst.The stent was not able to be deployed and was not implanted.

Manufacturer Narrative

Engineering analysis: upon opening the returned device it was noted that the stent was securely in place between the radiopaque marker bands.The diameter of the crimped stent was 2.2mm and is indicative of a properly crimped stent.The exposed balloon cones were inspected for visual damage that may be associated with the report that the balloon had burst.No damage was noted when inspected at 10x magnification.The catheter assembly was primed per the instructions for use supplied with the device.The catheter was then inflated to a nominal pressure of 8atm as listed on the product label and successfully deployed the stent.No leaks were noted.The balloon was then inflated to the rated burst pressure of 12atm as specified on the product label.The balloon showed no signs that it had burst and was able to maintain the 12atm pressure without issue.The catheter fatigue testing results and burst testing results indicate that this particular lot of v12 devices had a nominal burst value of 21.3 atm.The returned product performed perfectly.Engineering summary: a full review of the catheter lot history records for the device 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 10 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).Manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs.Result: all 59 quality inspection samples passed this final inspection without any non-conformances noted.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the device and or lot of stent delivery systems in question.The returned product had not burst and performed properly.

• 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: 5278732
• MDR Text Key: 33069569
• Report Number: 1219977-2015-00338
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Model Number: 85330
• Device Catalogue Number: 85330
• Device Lot Number: 227886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2015
• 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