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

Model Number 85452

Device Problems Loose or Intermittent Connection (1371); Device Contamination With Biological Material (2908)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

Engineering analysis: the complaint details provided indicate that the physician noticed stent was loose on delivery catheter before passing through the valve of the introducer sheath.Upon opening the returned device the stent was dislodged distally on the balloon but still on the balloon.The stent was blood covered and is not normal considering the stent never entered the introducer sheath.The shaft had a rather large kink in it at the proximal balloon bond as seen in the image below.The crimped stent leaves impressions of the stent frame on the surface of the balloon when properly crimped.The impressions indicate if the balloon was properly crimped.The stent delivery system balloon was inspected to ensure the crimped stent impression were visible.The crimped stent impressions were clearly present and are indicative of a properly crimped stent.The stent diameter was measured in the middle of the stent to determine if the diameter was in line with the quality inspection test data.The diameter was 2.12mm.This is slightly larger than the quality samples but is normal for a stent that has been dislodged.The average diameter from this lot of catheters was 2.1mm.The introducer sheath used in the case was not returned.Conclusion: we have not been able to determine any fault due to manufacturing.Conclusions of the investigation revealed that the delivery catheter had blood inside the catheter lumen.It was determined that the catheter must have penetrated the hemostatic valve on the sheath and had patient contact in order for this to occur.Determined to be a reportable event.

Event Description

Stent was on the wire being placed into the sheath and the physician noticed the stent was loose on the delivery catheter.The stent was never introduced into the sheath or into the patient.However, the returned product was covered with blood and had blood in the lumen of the catheter as if it had been used.

• 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; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 10 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5050170
• MDR Text Key: 24879501
• Report Number: 1219977-2015-00260
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2018
• Device Model Number: 85452
• Device Catalogue Number: 85452
• Device Lot Number: 224280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• 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: 74 YR