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

Model Number 85343

Device Problems Detachment Of Device Component (1104); Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a fenestrated endovascular aneurysm repair the stent came off the balloon as the stent was maneuvered into place.The stent was then partially deployed via the separate percutaneous transluminal angioplasty balloon but not at the target site.

Manufacturer Narrative

Engineering analysis: upon opening the returned device it was noted that the introducer sheath used in the case was not returned.The stent had been implanted and not returned with the delivery catheter.The balloon of the v12 product had been partially inflated only on the distal end of the balloon.The returned device balloon surface was evaluated to determine if the stent was crimped properly during manufacturing.The crimped stent impressions were clearly visible indicating that the stent was properly crimped during manufacturing.The balloon was then pressurized to ensure the integrity of the balloon had not been compromised and to ensure inflation media was seen coming out of the inflation lumen.The balloon was attached to a 20cc syringe and the balloon was slowly pressurized.A leak in the balloon was detected at the transition of the proximal balloon cone and dilatation zone area.Under magnification a small puncture of the balloon was seen.This leak would have prevented the proximal end of the balloon from inflating properly.As this device had been used in conjunction with an endograft there is a possibility that the balloon made contact with one of the fixation barbs of the endograft.The introducer sheath used in the case was not returned.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.The balloon burst data from over 80 samples tested from this particular balloon lot number of materials shows that all samples tested burst at over 19 atm and that the average burst value was 22.3 atm.The rated burst pressure for this product is 12atm.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.It is possible that the balloon made contact with one of the fixation barbs of the endograft but cannot be confirmed.

• 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 ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5253953
• MDR Text Key: 32269994
• Report Number: 1219977-2015-00334
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: 85343
• Device Catalogue Number: 85343
• Device Lot Number: 224275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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
• Treatment: CORDIS 4MM BALLOON
• Patient Outcome(s): Required Intervention
• Patient Weight: 93