MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENTS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85451

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 06/16/2014

Event Type  Injury  

Event Description

The stent slipped off the balloon when the doctor was trying to cross a tight lesion.He was able to retrieve the stent and used a new stent to finish the case.

Manufacturer Narrative

The product in question was not returned for evaluation, therefore an inspection to ensure the witness lines of the crimped stent were visible was not able to be performed (when the product is crimped, the stent struts impart permanent imprints to the exterior of the balloon).The diameter of the stent could not be measured to ensure that the diameter matched the measurements taken during the quality final inspection.The introducer sheath used in the case was not returned as well thus an inspection of the sheath dimension and overall condition could not be assessed.A full of 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 and nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 5 inflate.Result: the details of the complaint indicate that the stent was dislodged while attempting to pass the stent through a tight lesion.It is possible that the lesion was of a diameter that was smaller than the crimped stent outer diameter of the i-cast covered stent.This could cause the stent to dislodge if enough force was generated while attempting to pass the stent through the lesion.

• Brand Name: ATRIUM ICAST COVERED STENTS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 3960372
• MDR Text Key: 4555206
• Report Number: 1219977-2014-00205
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2014

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: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 85451
• Device Catalogue Number: 85451
• Device Lot Number: 10881195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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
• Treatment: 7 FR ANSEL 3 SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 65