MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85454

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Related mdr 1219977-2015-00242.

Event Description

The stent came loose on entry into the sheath.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the sample was removed from the bio-hazard bag and inspected to determine the cause of the complaint.On initial inspection the stent was no longer on the balloon and was shifted proximally up the catheter shaft.The balloon was still in the folded position and showed no signs of contrast fluid in the proximal or distal balloon cones.The stent and catheter showed no signs of bodily fluids, not even at the distal tip that would have entered the sheath prior to the stent making contact with the valve of the introducer sheath.The balloon surface was evaluated to determine if the stent was crimped properly during manufacturing, when the stent is crimped on to the folded balloon the stent frame leaves impressions on the surface of the balloon.The impressions indicate if the stent was properly crimped.The impressions were clearly visible indicating that the stent was properly crimped by manufacturing.The diameter of the stent was measured.The diameter was 2.18mm.This diameter is in line with the 59 samples measured during the product lot qualification testing.It is only slightly larger due to traveling over the proximal balloon cone when dislodged.The sheath used in the case was not returned.As the details indicate, this device was used in conjunction with an aaa endograft.It is possible that the sheath was damaged prior to advancing the icast covered stent into the valve of the sheath.This cannot be confirmed without the introducer sheath.The icast instructions for use specify the following, "do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered." 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 (b)(4) quality inspection samples passed this final inspection without any non-conformances noted.We have not been able to determine any fault due to manufacturing.

Manufacturer Narrative

This report is being submitted to link the hospital medwatch (b)(4) to our file.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: theresa morin ; 40 continental blvd; merrimack, NH 03054 ; 6038645237
• MDR Report Key: 5038188
• MDR Text Key: 24359576
• Report Number: 1219977-2015-00241
• 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,health
• Reporter Occupation: Nurse
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 85454
• Device Catalogue Number: 85454
• Device Lot Number: 226648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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