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

Model Number 85365

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923); Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the delivery catheter passed through the 7fr introducer without a problem.When trying to reach the target the surgeon noticed that the catheter was too short to reach the lesion.He decided to remove the delivery catheter with the stent crimped on.When trying to pass back into the introducer, the stent dislodged from the delivery catheter and was undeployed in the vessel.A surgical approach was necessary to recover the stent.No clinical consequence was observed.

Manufacturer Narrative

Analysis: the device in question was not returned.Based on the details of the complaint the physician, against the instructions for use, attempted to pull the unexpanded stent back through the introducer sheath.The instructions for use specify the following: extreme caution must be used when removal of an unexpanded or partially expanded stent is necessary.The stent/delivery system should be withdrawn until the proximal end of the stent is aligned with the distal tip of the sheath.The sheath and the stent/delivery system should then be removed as one unit.The reason for this instruction is that the proximal end of the stent can catch the distal end of the introducer sheath and push the stent off the balloon distally into the vessel.The data supplied within the device history records indicates that the stent retention values were 17.3 newtons and higher.The specification for stent retention is 5.5 newtons or higher.The 17.3 newton value far exceeds this specification.A full review of the catheter lot history records for the devices 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).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing associated with the complaint.There were no issues in regards to balloon failures in any of the test devices.In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification, stent securement testing; proximal balloon weld tensile testing; distal tip tensile testing.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the results of this investigation it appears that the stent was pushed off the balloon while attempting to pull the unexpanded stent back through the introducer sheath.Based on the successful product performance, inspection requirements being met and in process inspection requirements being met as indicated by the device history records review, atrium can find no fault with the product in question.Clinical evaluation: angioplasty is a procedure to open narrowed or blocked arteries.Fatty deposits can build up inside the arteries and block blood flow.Angioplasty and stent placement are two ways to open blocked peripheral arteries.The advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.The instructions for use (ifu) state as potential adverse effects, stent misplacement, migration or deformity.The ifu also warns do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.The ifu instructs to measure the length of the lesion to determine the length of stent required and that extreme caution must be used when removal of an unexpanded or partially expanded stent is necessary.The stent/delivery system should be withdrawn until the proximal end of the stent is aligned with the distal tip of the sheath.The sheath and the stent/delivery system should then be removed as one unit.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd.; merrimack, NH 03054
• MDR Report Key: 6983514
• MDR Text Key: 90430257
• Report Number: 3011175548-2017-00218
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/06/2020
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 247056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR