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

Model Number	85415
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Associated file 1219977-2016-00236.
Event or Problem Description
The physician inflated the balloon to deploy the stent in the renal artery.Then decided to inflate the balloon again.On the second inflation the balloon burst.The patient is fine.
Additional Manufacturer Narrative
Engineering analysis: upon opening the returned device packaging it was noticed that the icast covered stent system was still inside the introducer sheath.The balloon had a radial tear 4mm past the proximal balloon weld.The proximal balloon weld was fully intact.The balloon was inverted on the catheter shaft over the distal balloon bond that was also fully intact.The stent was not present with the returned delivery system.The balloon was inspected to determine the cause of the rupture.Because of the destructive nature of the burst failure mode of a radial tear an exact location of the burst could not be determined.It is extremely rare to have a balloon tear in a radial fashion.Balloons are designed and created to burst in a longitudinal fashion under normal circumstances.The device history records attached to this complaint indicate that all the balloons that were burst tested (49 balloons total) burst with longitudinal tears as expected.Based on the nature of the radial tear in conjunction with the deployment of an endograft there is a possibility the proximal balloon cone made contact with a fixation barb of the endograft after successfully deploying the stent.Engineering summary: 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.Clinical evaluation: endovascular aneurysm repairs require the delivery catheter to advance through a previously placed vascular graft that is secured via barbs to the walls of the aorta.If the stent balloon comes in contact with one of these barbs, or calcification in the vessel it may burst on inflation and the stent may not have achieved good opposition to the vessel wall.This could cause a delay in the procedure while an additional balloon was located and prepped.The instructions for use warn that inadvertent, partial or failed deployment of the device may require surgical intervention and that balloon pressures should be monitored during inflation.It warns not to exceed maximum recommended inflation pressures as indicated on the product label as this pressure increases the potential for balloon rupture and possible damage.

• Brand Name: ATRIUM ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 6112052
• Report Number: 1219977-2016-00235
• Device Sequence Number: 16233969
• Product Code: JCT
• UDI-Device Identifier: 00650862854152
• UDI-Public: 00650862854152
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/25/2019
• Device Model Number: 85415
• Device Catalogue Number: 85415
• Device Lot Number: 242439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention