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

Model Number 85406

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a stent was successfully placed in the left common iliac artery.When the physician went to remove the balloon it would not fit back into the sheath.The sheath and balloon had to be removed at the same time.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the catheter which was still within the sheath was removed from the bio-hazard bag and was decontaminated.The balloon was in good condition with no signs of damage or stress.The catheter shaft was also in good condition but was wavy from being coiled up in the return package.There was a small area at the intersection where the catheter shaft exited the proximal end of the introducer sheath where the shaft had been necked down due to pulling on the catheter shaft.The balloon was half way inside the distal end of the introducer sheath.The introducer sheath was inspected for damage and the tip of the sheath had visible damage around the entire edge.The portion of balloon still remaining outside the introducer sheath was folded down nicely and showed no signs of stress.Tension was applied to the proximal end of the catheter to see if the balloon could be withdrawn into the sheath.The balloon and catheter were pulled back through the introducer sheath very easily with minimal resistance.A 0.035"in cook emerald green guide wire was inserted through the length of the catheter and the balloon pushed back through the introducer sheath.The balloon was inflated to 12atm as specified on the product label.This is the rated balloon burst pressure.The balloon was then deflated and was again withdrawn back through the sheath with very little resistance.This was repeated 2 addition times without issue.The distal tip of the introducer sheath was measured and was.097"in.This diameter is a normal diameter of a 7fr introducer 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.· 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: the lack of visual damage to the balloon indicates that balloon deflation, balloon refolding, and balloon withdrawal from the stent itself are not root cause concerns for this complaint.Attempts to duplicate the inability to remove the catheter from the introducer sheath could not be replicated.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 withdrawn back into a sheath it would cause a prolonged procedure and increase the patients risk by potentially subjecting them to additional medical or surgical intervention.It is stated in the instructions for use, "do not force passage or withdrawal of the guide wire or delivery catheter if resistance is encountered.".

• 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: 5897420
• MDR Text Key: 52830764
• Report Number: 1219977-2016-00182
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854060
• UDI-Public: 00650862854060
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/18/2019
• Device Model Number: 85406
• Device Catalogue Number: 85406
• Device Lot Number: 238883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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: 50 YR