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

Model Number 85407

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician deployed the stent into the distal aorta.He felt resistance while trying to pull the balloon out of the sheath.The balloon became detached inside the sheath.The physician was able to retrieve the balloon with no complications.

Manufacturer Narrative

Engineering analysis: the returned device was removed from the bio-hazard bag and inspected.On initial inspection the balloon had become detached from the catheter shaft at the proximal balloon weld.The balloon bond itself did not break.The shaft had necked down to a smaller diameter due to excessive force being applied to the shaft prior to breaking just before the balloon bond.There was a radial to longitudinal tear toward the proximal end of the balloon.There was also another tear in the center of balloon dilatation zone.The shaft, upon inspection, had been elongated approximately 2.5cm during the attempts to remove the catheter through the introducer sheath.The introducer sheath used in this case was not returned.A review of the complaint details states that the lesion was calcified.It is possible that the balloon was ruptured during the procedure on the calcification.If this was the case it would make removal of the balloon difficult as the balloon would not be able to deflated using traditional techniques.The details also mention the doctor does not aspirate the balloon to remove the contrast but allows passive deflation of the balloon.The instructions for use specify the following in regards to balloon deflation and removal: "using an inflation device, deflate the balloon.Allow adequate time for full balloon deflation.Very slowly withdraw the balloon from the icast covered stent, maintaining negative pressure.While maintaining the position of the guidewire (if used) across the treated lesion, carefully withdraw the balloon catheter through the lumen of the device and remove it under fluoroscopic visualization".A review of the lot history data indicates that this lot of catheters at final lot qualification testing had balloon burst values exceeding 18atm.This icast product has a rated burst pressure of 12atm.The average burst values of 59 samples tested was 21atm.This far exceeds the 12atm product rating.The bond strength requirement for the proximal balloon weld is a minimum of 15n (newton, [n].One newton is equal to 3.372 pounds of force).This means that over 15n (50.58 pounds) of force was generated during the attempts to remove the balloon back through the sheath.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).Result: all 59 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: if a balloon cannot be inflated or ruptures and a part of the component breaks off it would cause a procedural delay and increase the patient's risk by subjecting them to additional medical or surgical intervention.The ifu states as a contradiction the use of the icast 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.

• Brand Name: ATRIUM ICAST 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: 5897425
• MDR Text Key: 52834117
• Report Number: 1219977-2016-00183
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854077
• UDI-Public: 00650862854077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

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
• Device Operator: Physician
• Device Model Number: 85407
• Device Catalogue Number: 85407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 59 YR