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

Model Number 85325

Device Problem Torn Material (3024)

Patient Problem Thrombosis (2100)

Event Date 05/20/2016

Event Type  Injury  

Manufacturer Narrative

Associated file: 1219977-2016-00119.On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that during a kissing procedure on the iliac arteries one of the balloons tore when inflating.Both stents were correctly deployed.Three weeks later the patient presented with pain and required a second intervention due to a thrombosis.

Manufacturer Narrative

Engineering analysis: the piece of balloon was removed from the bio-hazard bag and disinfected.Upon initial inspection the piece of balloon was either the proximal or distal balloon cone with a small segment of the balloon being in the dilatation zone.There was a small longitudinal tear in the balloon cone.The tear otherwise was circumferential.The inflection point where the balloon neck meets the balloon transition zone had a complete radial tear around the area where the balloon neck is supposed to be.This balloon neck is welded to the catheter shaft by thermally bonding the two materials together creating a welded joint.The catheter shaft and sheath were not returned.Only the balloon fragment was returned.The details indicate that this procedure was a kissing stent procedure where both stents are to be deployed simultaneously.Multiple questions where requested of the physician and are attached to the complaint files and listed in the background information provided above.One of the questions that were not answered was what pressure used to deploy the stent.The rated burst pressure for this advanta v12 catheter is 12atm and is listed on the product label.A review of the data collected during the process of creating the balloon of the catheter indicates that the lowest burst pressure of 53 samples tested was 18.3atm with an average burst value of 20.5atm.This testing is conducted after 5 full cycles of the balloon being inflated to the rated burst pressure of 12atm and then deflated (fatigue testing).The details also indicate that when the balloons were burst test the failure mode was that all balloons ruptured with longitudinal tears.No radial tears were observed during this testing.Based on the details provided it is possible that the balloon, upon deployment, ruptured against the other stent that was deployed simultaneously in this kissing stent procedure.It is also possible that the balloon during this process was pressurized over the rated burst pressure of 12atm as listed on the product label.In this case it is odd that the ruptured balloon fragment was not noticed during or after the procedure as it would have been very evident if the balloon were inspected upon removal of the catheter as this fragment was large.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 quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.During this lot qualification testing none of the balloons ruptured in a radial fashion and all samples burst with a value of no less than 19.6atm.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: it is not surprising that balloon ruptures occur in the target vessel stents used in endovascular aneurysm repairs.Such stents and their balloons are subjected to forces due to respiratory movement of the viscera, longitudinal movement of the endograft, circumferential forces due to aortic diameter changes, and side branch motion during the cardiac cycle.If the fenestrated endograft is not perfectly positioned within the native anatomy the device will be subjected to additional stress as they are forced to realign to accommodate the geometrical mismatch.Causes of balloon rupture in these cases include contact with the graft, angle of the target and disease state of the target.The ifu states 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.Balloon rupture may result in residual fragments and this may cause vascular occlusion and tissue injury if not detected.This would increase the patients risk by subjecting them to additional medical or surgical intervention.

• 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 rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5709463
• MDR Text Key: 46906313
• Report Number: 1219977-2016-00118
• Device Sequence Number: 1
• Product Code: NIO
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: 85325
• Device Catalogue Number: 85325
• Device Lot Number: 228248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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
• Patient Age: 61 YR