MAUDE Adverse Event Report: INVATEC SPA AMPHIRION DEEP PTA BALLOON CATHETER; CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article: journal of vascular surgery volume 63, number 2 society for vascular surgery ¿paclitaxel-coated versus plain balloon angioplasty in the treatment of infrainguinal vein bypass stenosis¿.Doi:10.1016/j.Jvs.2015.08.081.

Event Description

The aim of this study was to compare the clinical and hemodynamic outcomes of plain vs paclitaxel-coated percutaneous transluminal angioplasty (pta) in patients with infrainguinal vein bypass stenosis.A single-center retrospective analysis was conducted of consecutive patients treated by infrainguinal bypass pta.Primary study end points were primary and assisted primary patency.Secondary end points were clinical and hemodynamic improvement, limb salvage, and survival.Four vascular surgeons performed both plain and drug coated balloon angioplasty, whereas one surgeon inclined to dcb catheters only.For plain balloon angioplasty admiral xtreme, pacific xtreme, and amphirion deep balloon catheters were used.For dcb angioplasty in.Pact admiral, in.Pact pacific, and in.Pact amphirion balloon catheters were used.In case of distal origin bypass grafts or in case of very distal bypass stenosis, antegrade pta with puncture of the ipsilateral cfa was the preferred technique.Postprocedural antithrombotic treatment in group a was aspirin (100 mg) only in 28 patients, aspirin and anticoagulation in 8, clopidogrel (75 mg) only in 3, and clopidogrel (75 mg) combined with anticoagulation in 2, and in group b was aspirin (100 mg) only in 30, aspirin and anticoagulation in 4, clopidogrel (75 mg) only in 3, and clopidogrel (75 mg) with anticoagulation in 5.From april 2008 to november 2014, 83 infrainguinal vein bypasses were treated for graft stenosis by plain (group a, n 41) or by pacl itaxel-coated pta (group b, n 42).Technical success rate was 100% for both groups.Mean follow-up was 2.9 years for group a patients and 2.2 years for group b patients.No patient was lost to follow-up.Primary patency rates were 88% vs 87% and 73% vs 75% and assisted primary patency rates were 88% vs 90% and 77% vs 84% for group a and b patients at 1 and 2 years, respectively.Repeat target lesion revascularization rates were 22% vs 14%.At the last follow-up, there were eight vs seven bypass occlusions for group a and b patients, respectively.Immediate hemodynamic and sustained clinical improvement rates were 88% vs 86% and 70% vs 73% for group a and b patients, respectively.There were three vs one major amputation and eight vs seven deaths in group a and b patients, respectively.The most common cause of death was cardiac failure due to coronary artery disease.Local complications were observed as pseudoaneurysms of the cfa (1 in group a, 2 in group b).All pseudoaneurysms had to be handled surgically.Limb salvage rates were 93% for group a patients and 98% for group b, and there were three major amputations in group a and one major amputation in group b (p 1/4.36).All major amputations were performed due to progressive gangrene.Repeat target lesion revascularization rates were 22% in group a and 14% in group b (p 1/4.17).Seven successful repeat angioplasties were performed using plain balloon catheters for high-grade stenoses in group a, comprising proximal anastomosis in 2, distal anastomosis in 4, middle in-graft stenosis in 1, and stenosis of adjacent vessels in 2.Three successful reinterventions were performed using paclitaxel-coated balloons for significant stenoses in group b, consisting of proximal anastomosis in 1, distal anastomosis in 2, and stenosis of adjacent vessels in 2.Stent deployment was not indicated in patients undergoing bypass redo pta.All reinterventions (5 of 15 [33%]) for bypass occlusion (group a: thrombectomy in 1, lysis in 2; group b: lysis in 2, thrombectomy in 1) failed.In 10 of 15 bypass occlusions (67%), no salvage procedure was performed.Because occluded bypasses could not be saved, assisted primary patency rates and secondary patency rates were the same.Conclusions: paclitaxel-coated and plain angioplasty of significant infrainguinal vein bypass stenoses performed equally well in clinical and hemodynamic improvement and in primary and assisted primary bypass patency rates.

Manufacturer Narrative

(b)(4), unapproved or contraindicated use (the use of the device in infrainguinal vein bypass stenosis is not indicated in the ifu).

• Brand Name: AMPHIRION DEEP PTA BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5456310
• MDR Text Key: 38860868
• Report Number: 3004066202-2016-00057
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K052791
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• 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
• Patient Age: 00072 YR