MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT

Model Number 85339

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

The procedure was a stenting of a celiac artery.As the doctor was advancing the stent they noticed it wouldn't advance.The stent was removed and a kink was noted.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the v12 was removed from the packaging and inspected to determine the cause of the complaint.The delivery system was decontaminated and inspected for damage.There was noticeable kinking of the catheter and shaft damage seen just before the proximal balloon bond.This kink in the shaft would not be possible if a guide wire were in place.It is believed that there was no guide wire in place when this kink occurred.The stent was centred between the two ro marker bands and was securely in position.Engineering summary: 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 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 at 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/deflate cycles at the rated burst pressure (12atm) without leaks or failures.· balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).· manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing related to the catheter shaft.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the device and or lot of stent delivery systems in question.Clinical evaluation: an introducer sheath is used during endovascular interventions to provide a stable access to the vascular system.The delivery catheter is soft and becomes softer at body temperature.In order to advance a delivery catheter through the sheath a guide wire is needed for support.If a guide wire is not used the sheath may buckle or kink and the catheter would not advance through the vasculature.Insufficient stent wire support during access through the sheath may lead to the need for removal of the stent delivery system.The instructions for use state "standard techniques for placement of a sheath and guide wire should be employed when using this device." also, "do not force passage or withdrawal of the delivery system if resistance is encountered.".

• Brand Name: ATRIUM ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• 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 rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5647906
• MDR Text Key: 44997356
• Report Number: 1219977-2016-00096
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/19/2019
• Device Model Number: 85339
• Device Catalogue Number: 85339
• Device Lot Number: P16035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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: 89 YR
• Patient Weight: 75