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

Model Number 85417

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was undergoing a thoracic endovascular graft placement with an icast stent.Prior to launching of the stent it came loose from the sheath.The product was removed fully intact.No harm came to the patient.

Manufacturer Narrative

Engineering analysis: the complaint details provided indicate that the stent dislodged off the balloon within the introducer sheath.The returned device was removed from the packaging and inspected to determine the cause of the dislodgement.Upon inspection, the icast stent was still crimped onto the balloon and was not loose on the balloon.The stent was properly positioned between the two radiopaque ro marker bands.The diameter of the stent was measured and was 2.4mm.This diameter is indicative of a properly crimped stent and is in line with the rest of the measurements documented within the quality inspection records.The introducer sheath used in the case was not returned.To determine if the icast delivery system and stent performed properly the returned device was prepped per the instructions listed in the instructions for use(ifu).The balloon was inflated to the nominal inflation pressure of 8atm.The stent opened properly within the ro marker band and the stent did not move.The pressure was then increased to the rated burst pressure of 12atm as specified on the product label.The product performed as expected.There are no indications that the stent was dislodged.The return details provided indicate that the stents intended target was the celiac trunk.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 59 quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing related to the stent.All samples passed through the introducer sheath without any stent dislodgments.During the final lot qualification data shows that all 59 test samples were able to pass through the 7fr introducer sheath without issue.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the device and or lot of stent delivery systems in question.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5463985
• MDR Text Key: 39195300
• Report Number: 1219977-2016-00027
• Device Sequence Number: 1
• Product Code: JCT
• 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,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 231925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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: 75 YR
• Patient Weight: 90