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

Model Number 85405

Device Problem Detachment Of Device Component (1104)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 07/03/2014

Event Type  Injury  

Event Description

A report was received about a planned intervention on the left common iliac in a heavily calcified vessel.There were lots of issues event getting wire access.When the stent was advanced the physician met with a lot of friction.The physician decided to remove the stent.The stent came off the balloon and was lodged in the superficial femoral artery up against the calcified area.The physician still planned to stent the iliac after doing an open endarterectomy (surgical removal of plaque from a vessel).

Manufacturer Narrative

Engineering analysis: the returned stent delivery system was removed from the bio-hazard bag and inspected.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 and overall condition could not be assessed.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 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.Results: 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.Conclusion: based on the details of the reported event atrium can find on 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: 3986433
• MDR Text Key: 20860698
• Report Number: 1219977-2014-00216
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/04/2014

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: 03/30/2016
• Device Model Number: 85405
• Device Catalogue Number: 85405
• Device Lot Number: 10885187
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: COOK SHEATHS AND WIRES
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR