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

Model Number 85419

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/18/2014

Event Type  Injury  

Event Description

During endovascular abdominal aortic aneurysm repair case, a stent came off the balloon while attempting to go into 7fr x 55 raabe sheath.The physician following the wire back via x-ray with no determination of stent location.It was only when the physician looked down at his sheath, that he observed that the stent was on the wire and had not crossed the hemostatic valve.The stent was removed and a new one was selected and inserted without complications.

Manufacturer Narrative

The returned stent delivery system was removed form the bio-hazard bag and inspected.The stent was dislodged from the balloon and was proximal up the shaft toward the inflation manifold.The stent was in the crimped position and slightly flared on both ends as it had been pushed up and over the proximal balloon cone.The center of the stent was measured using calipers and found to be 2.4mm.This diameter is indicative of a properly crimped stent.The balloon was in good condition and in the folded position.The balloon was inspected to ensure the witness lines of the crimped stent were visible.The imprints of the stent frame were clearly visible and are indicative of a properly crimped stent.The introducer sheath used in the case was not returned; therefore, an inspection of the sheath dimensions overall condition could not be assessed (this is important as the complaint details indicate that the stent was dislodged while passing through the hemostasis valve).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 atrium's 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 10 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Result: all catheters passed this final inspection.No stent dislodgements were noted during the performance testing and all samples passed through the introducer sheath without a dislodgement or damage.Engineering summary/conclusion: 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 then 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.Conclusion: based on the details of the reported event atrium can find no fault with the device lot in question.

• 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: 3960373
• MDR Text Key: 4559299
• Report Number: 1219977-2014-00204
• 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: 08/31/2016
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 10902354
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2014
• 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?: Yes
• Date Device Manufactured: 08/01/2013
• 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: 0.035 X 300 ABBOTT SUPRA CORE; 7FR 55CM COOK RAABE INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 95