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

Model Number 85419

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Associated file: 1219977-2016-00219.

Event Description

The procedure was a fenestrated endovascular aneurysm repair.The access was femoral contralateral approach.It was very tight going up and over.The physician pushed very hard several times.He then pulled back and the catheter accordioned.

Manufacturer Narrative

Additional information: sex.Engineering investigation: upon opening the returned device packaging it was noticed that only one of the two devices detailed in the complaint was returned.There were two icast boxes returned and were both 9mm x 59mm x120cm products however both devices were produced from the same production lot of catheters.The stent, when evaluated, had a significant bend to it presumably from tracking up and over the iliac arch.The catheter shaft had been accordioned at the proximal end as described in the complaint details.The crimped stent diameter was measured and was 2.5mm and is indicative of a properly crimped stent.The stent was in its original crimped position.To determine if the device was still functional an 0.035 wire was placed up through the distal end of the catheter guidewire lumen.The wire could not pass through the damaged section of the shaft.The device was then prepared per the instructions for use supplied with the product.The stent was then deployed to 8atm as specified on the product label.The balloon was then pressurized with the stent still in position to the rated burst pressure of 12atm also specified on the product label.The icast stent and delivery system performed properly without any abnormalities noted.The product performed as expected even with the damage to the shaft as described above in the complaint details.The damage of the shaft described as accordioned was caused by excessive force being applied to the catheter shaft during attempted advancement.The instructions for use specify the following caution: "if resistance is encountered do not force passage".The doctor was instructed to use the properly sized sheath during the procedure on more than one occasion but did not follow the advice of the sales representatives that the sheath was too large.The label of the icast stent delivery system clearly states to use a 7fr introducer sheath with this product.Engineering summary: a full review of both the devices used case catheter lot history records for the devices in question was performed.The records indicate that both lots 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.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.Clinical evaluation: arterial disease is usually caused by a build-up of fatty deposits on the walls of the arteries.Ischemia is a restriction in blood supply to tissues caused by an occlusion and resulting in a shortage of oxygen needed at the cellular level.Percutaneous transluminal angioplasty (pta) and stenting are frequently done to treat vascular occlusions with the intention of restoring blood flow through the occluded arteries.A delay in treatment would affect the success of reperfusion of that tissue.It was reported that the physician was unable to advance the delivery catheter to the target lesion.The instructions for use state, "do not force passage or withdrawal of the guide wire or delivery system if resistance is encountered." the instructions for use also recommend that special care should be taken to ensure that the appropriate size device, guide wire and sheath are selected prior to introduction.Native lumen dimensions must be accurately measured not estimated.Associated file: 1219977-2016-00220.

• Brand Name: ATRIUM ICAST 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: 6041679
• MDR Text Key: 57879776
• Report Number: 1219977-2016-00220
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854190
• UDI-Public: 00650862854190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/08/2019
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 241949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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