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

Model Number 85424

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Mdr report received from user facility regarding an event that occurred in (b)(6) 2015.Hospital medwatch was not numbered.The report stated that a 10x38x80 icast was pulled off the shelf, but a 10x38x120 was in the box.Product search revealed: (b)(4) product was sold to ((b)(4) on (b)(6) 2012.Expiry date 1-jan-2015.(b)(4) product was sold to (b)(4) on (b)(6) 2012.Expiry date 31-jul-2015.Multiple attempts were made to obtain information with no success.Repeat messages resulted in no response from the hospital contact.No product or packaging was returned.Each product lifecycle was examined and it was discovered that the products were manufactured and sold 6 months apart to two different institutions.It has been determined that this was not a manufacturing error as the products were manufactured and sold 6 months apart.The mdr is being submitted in response to the user facility medwatch received as it is not a reportable event.

Event Description

It was reported that a 10 x 38 x 80 icast was pulled off the shelf, but a 10 x 38 x 120 was in the box.

Manufacturer Narrative

Medwatch # mw5056060 received on 26-oct-15 (attached).Mdr send to link medwatch received with mdr 1219977-2015-00300.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5147029
• MDR Text Key: 28347729
• Report Number: 1219977-2015-00300
• 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: Health Professional
• Type of Report: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2015
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 10818982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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 Age: 60 YR