MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FOGARTY; CATHETER, EMBOLECTOMY

Model Number 120804FP

Device Problems Material Puncture/Hole (1504); Material Rupture (1546); Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2022

Event Type  malfunction  

Event Description

Elderly male with occluded graft post-left brachial artery to axillary vein graft.Team noted that the embolectomy catheters 4f had hole in them straight out of package.Please note: no patient harms.That there were 3 in same case was a concern of the operating room team.Operation: open thrombectomy of the left brachial artery to axillary vein graft.Insertion of sheath into the graft with graft angiogram.Placement of self-expanding covered stent (gore viabahn 7 mm x 5 cm) at the venous anastomosis.Preoperative diagnosis: end stage renal disease.Thrombosed left upper extremity dialysis access graft.Indications for procedure: elderly male in whom i placed a left brachial artery to axillary vein graft (gore acuseal 6 mm) who was found at dialysis to have an occluded graft recently.Due to weather, he was unable to get to hospital until yesterday.Given that he was without dialysis for 4 days, it was arranged for him to get a catheter yesterday and undergo dialysis yesterday with procedure today.I met with the patient and offered him left upper extremity arteriovenous graft thrombectomy, graft angiogram, and possible stent placement.We discussed the risks (bleeding, infection, need for additional procedures in the future) and benefits (continued durable dialysis access).Following this discussion and a chance to answer his questions, he wished to proceed and signed procedure consent.Operative findings: prior arterial anastomosis incision was used.Transverse graftotomy made.I was able to remove the thrombus from the arterial limb with intact meniscus.I then passed a #4 fogarty toward the venous anastomosis.I was able to perform thrombectomy, but the balloon deformed at the site of the venous anastomosis.Once there was a clean pass and back-bleeding, i inserted a sheath into the graft and performed angiogram.Based on this, i selected a 7 mm x 5 cm gore viabahn self-expanding covered stent, and this was placed at the level of the venous anastomosis and post dilated with a 7 mm angioplasty balloon.The graft was closed primarily.Following this, there was a brisk thrill in the graft and a persistent palpable left radial pulse.The patient tolerated the procedure without incident.Description of procedure: after obtaining informed consent, the patient was brought to the operating room and placed in the supine position.General anesthesia was induced and the patient's left upper extremity was then prepped and draped in the usual sterile fashion.A preoperative timeout was performed which confirmed that the correct patient as well as procedure that was being performed.I used the prior scar overlying the arterial anastomosis as a guide and made a small longitudinal incision at this level overlying the graft.The graft was circumferentially exposed over a short distance.The patient was given 3000 units of iv heparin.A transverse arteriotomy was made with an 11 blade.I was able to remove the thrombus from the arterial limb with an intact meniscus and brisk inflow.Soft jaw fogarty clamp applied to the graft.I then passed an 018 wire and an over the wire fogarty catheter into the axillary vein.The balloon inflated initially, but clearly ruptured and the balloon and wire were removed.I then selected a standard #4 fogarty thrombectomy catheter.This was passed in the venous limb of the graft into the axillary vein.I then performed thrombectomy removing abundant thrombus.I then had a clean pass and brisk back bleeding.I inserted a the 7f sheath and applied tension to a vessel loop for hemostasis.I then inserted the v18 wire through the sheath into the axillary vein.I then performed angiogram of the graft and left upper extremity veins.There was a high grade stenosis at the venous anastomosis.I selected a 6 mm x 4 cm angioplasty balloon and performed balloon angioplasty of the venous anastomosis.Further angiogram performed.I then selected a 7 mm x 5 cm gore viabahn covered stent and this was deployed across the venous anastomosis.I then selected a 7 mm x 4 cm angioplasty balloon to post dilated the stent.Further angiogram was performed.I then removed the wire and the sheath and applied a fogarty clamp.I then closed the transverse graftotomy in an interrupted fashion with 6-0 prolene.Flow was re-instituted.There was an immediate strong thrill in the graft and the patient retained a palpable left radial pulse.The incision was thoroughly irrigated, and hemostasis was confirmed.The incision was closed in layers using 3-0 vicryl for the deep dermis and then 3-0 nylon suture for the skin.Dermabond was applied to the skin.A thrill was appreciated over the graft following closure and the patient retained a palpable left radial pulse.Patient was then awaken from anesthesia.Interpretation of imaging: patent graft and axillary vein.70% stenosis associated with the venous anastomosis.Following balloon angioplasty this improves.Following stent deployment, there is no residual stenosis and persistent patency of the axillary vein.

• Brand Name: FOGARTY
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13809851
• MDR Text Key: 287422575
• Report Number: 13809851
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 120804FP
• Device Catalogue Number: 120804FP
• Device Lot Number: 63340221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White