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

Model Number 85417

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician placed a stent in the right common iliac artery.It was noted that the balloon had popped because blood was noticed in the inflator.While trying to retrieve the popped balloon it appeared to be sheared off the stent catheter.Multiple attempts were made to remove the balloon unsuccessfully.The decision was made to leave the balloon in the common iliac and place additional stents over it to maintain blood flow.The solution was successful and the patient was unharmed.

Manufacturer Narrative

Additional information pt identifier, age/date of birth, sex and weight.Engineering analysis: upon opening the returned device packaging it was noticed that the balloon was no longer attached to the stent delivery system.The shaft had been necked down to a smaller diameter where the break in the shaft occurred.The necked down shaft diameter was.041 inches.The normal diameter of the shaft is.060 inches.The location of this break was 114 cm from the strain relief of the catheter manifold.There was an additional area of shaft necked down approximately 80 cm from the manifold strain relief.The shaft diameter at this location was.047 inches.The details indicate that the lesion was not pre-dilated and that the physician did not meet very much resistance when removing the ruptured balloon.The test data provided within the device history records of this device indicate that out of the 20 test samples that were destructively performance tested for proximal balloon bond weld strength, the minimum bond strength was 27 newtons (n) or 6 lbs.The specification for this is 10 n.All data suggests that this lot of icast stents more than doubles the requirement.Based on the details provided it is unclear as to why the balloon ruptured on deployment.The physician said the balloon did break on inflation.It was also noted that the pressure was taken above the rated burst rate but the actual pressure was not noted.The label on the icast pouch and outer box specify not to exceed the rated burst pressure of 12 atm.The details also state that the balloon was snared but was left in the vessel as it could not be withdrawn back into the introducer sheath.The product in question during design verification testing has also been subjected to simulated use in a tortuous iliac artery model whereas the stent delivery system is advanced contra laterally over the iliac arch through a 7fr 55 cm long cook check flow performer introducer sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during design verification testing of the product.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 (8 atm).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 (12 atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12 atm).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: balloon rupture may be the result of several causes including, but not limited to, advancing the device through tortuous or calcified anatomy or getting hung up on a previously placed device such as a graft or stent.When a balloon ruptures and a part of the component breaks off, retrieval of the residual fragments is possible; however, this may require the use of large sheaths and surgical closure of the puncture site.This could result in a procedural delay and could increase the patients risk by subjecting them to additional medical or surgical intervention.The instructions for use state as a contraindication 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: 6112053
• MDR Text Key: 60287966
• Report Number: 1219977-2016-00232
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854176
• UDI-Public: 00650862854176
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

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 Expiration Date: 03/29/2019
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 236211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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: 73 YR
• Patient Weight: 94