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

Model Number 85353

Device Problem Burst Container or Vessel (1074)

Patient Problem No Code Available (3191)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure on an occlusive left renal artery the balloon burst.A new balloon was introduced and the stent was deployed properly.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the sample was removed from the bio-hazard bag and inspected to determine the cause of the complaint.The case details indicate that the v12 was unable to maintain pressure above 4atm when the stent was attempted to be deployed.Upon inspection of the returned device the balloon had seen positive pressure but not enough pressure to deploy the stent.The delivery system was disinfected and then was attempted to be pressurized.Upon applying the positive pressure to the balloon using water, the balloon had a noticeable leak just prior to the distal radiopaque ro marker band.Upon close inspection of this leak at 20x magnification a hole was noticed at the top of one of the folded balloon pleats.This leak would be considered a gross leak as pressure beyond 1atm could not be achieved.Atrium medical 100% pressure tests and inspects every balloon at 12atm.The data from the quality performance inspections shows that out of the 30 samples out of the 59 samples burst tested, all samples burst at over 19atm.In addition to the 30 assembled catheter inspections, the individual balloons are inspected 100% at the balloon forming operation for cosmetic defects and every 11th balloon is fatigue tested.This testing requires the balloon to withstand 10 inflate/deflate cycles at the rated burst pressure of 12atm followed by burst testing.The balloon of this device is also protected by the use of a ptfe sheath during the stent crimping procedure to ensure the balloon is not damaged.Determining the root cause of the hole in the balloon proves to be difficult as the product could have been damaged at any point once it was opened and entered the sterile field by a sharp object as the appearance of the failure was that of contact with a sharp object.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 10 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 59 quality inspection samples passed this final inspection without any non-conformances noted.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.

• Brand Name: ATRIUM ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 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: 5313216
• MDR Text Key: 33937947
• Report Number: 1219977-2015-00349
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 224293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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
• Patient Weight: 74