MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 COVERED STENT; STENT, RENAL

Model Number 85353

Device Problem Retraction Problem (1536)

Patient Problem Thrombosis (2100)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician stated he was placing a fenestrated device within an old endovascular aneurysm repair (evar) graft.The left renal target was difficult but not calcified; size small (5-6 mm).The stent was positioned without difficulty.The sheath was pulled back.On inflation and with minimal pressure achieved, and with only very slight flaring of the proximal and distal ends of the stent, contrast was seen from the balloon down into the renal and inflation was stopped.He could not withdraw the balloon so he attempted further inflation by just inflating very quickly and managed to get enough dilatation of the stent to withdraw the delivery device/balloon.He then used an angioplasty balloon (4x40) to inflate the stent, however it thrombosed.He restented with a be graft.

Manufacturer Narrative

Analysis: the returned device was disinfected and inspected under 30 x magnifications for signs of a balloon leak.No leak had been identified.The balloon was then pressurized with water and a small pinhole leak was detected within the proximal balloon cone 1mm from the dilatation zone of the balloon.An image of the pinhole is below.It appears to be a puncture hole and there is a small scratch leading up to the pinhole site.There were no other signs of damage on the catheter.Eight atmospheres of pressure could be reached even with the pinhole leak however the balloon could not maintain this pressure.A review of the device history records indicates that the balloon burst test data of 49 samples from this lot of balloons catheters had a minimum burst value of 19.4 atmospheres.The rated burst pressure of the v12 balloon is 12 atmospheres.The burst data shows that the balloons are rupturing well above the acceptance criteria of 12 atmospheres.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of v12 covered stent systems is tested to.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 (6fr); 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).This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Conclusion: based on the review of the complaint details and the device history records review atrium medical cannot conclude that the balloon rupture was a fault of the design or manufacture of the device.It is possible that the balloon made contact with one of the fixation barbs of the endograft, this however cannot be confirmed.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7601245
• MDR Text Key: 111059955
• Report Number: 3011175548-2018-00604
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2020
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 422402
• Other Device ID Number: 00650862853537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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: 7FR OSCOR DESTINATION SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 80