MAUDE Adverse Event Report: INVATEC TECHNOLOGY CENTER GMBH IN.PACT ADMIRAL; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

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

Patient Problem Vasoconstriction (2126)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The purpose of this study was to evaluate the safety and feasibility of using drug-eluting balloons (debs) in the treatment of infrainguinal bypass graft stenosis.Between (b)(6) 2010 and (b)(6) 2012, a physician-initiated, nonrandomized, prospective study was conducted to test the feasibility of deb treatment for bypass graft stenosis.All patients who manifested intragraft/anastomotic stenoses more than 1 month after infrainguinal bypass grafting (vein or prosthetic conduit) were eligible for deb treatment; stenoses due to graft/technical problems (e.G., vein torsion) were excluded from the study.41 patients were treated with debs for 63 anastomotic/intragraft stenoses in vein or prosthetic grafts.Follow-up was performed with duplex ultrasonography.Two models of in.Pact paclitaxel-eluting balloons were used: amphirion (2, 2.5, 3, and 3.5 mm diameters) and admiral (4 to 7 mm diameters).Predilation (2 minutes) with an uncoated balloon sized according to the baseline duplex scan was performed to ensure unimpeded insertion of the debs, which were sized 0.5 mm larger than the uncoated balloon to guarantee contact with the arterial wall.For stenosis below the popliteal artery, the debs were sized according to the diameter of a normal runoff vessel segment distal to the anastomosis.Inflation time was at least 1 minute to allow elution of the paclitaxel.In general, the inflation pressures and times were in the range of 8 to 12 atmospheres and 2 to 3 minutes, respectively.Digital subtraction angiography (dsa) after each procedure recorded the balloon dilation site and runoff vessels to assess diameter improvement and potential complications.In case of flow-limiting dissection or residual stenosis >30%, prolonged dilation up to 5 minutes was performed.No closure devices were employed.Post-intervention dual antiplatelet therapy with aspirin and clopidogrel) was given at least for 4 weeks, with aspirin continued indefinitely thereafter.Results: a total of 63 interventions were performed on 22 femoropopliteal, 16 femorotibial, and 3 popliteal-pedal bypasses: 26 grafts underwent a single revision, 15 grafts had multiple revisions for metachronous stenosis, and 7 grafts were treated for recurrent lesions over a mean 15 months after graft revision.All debs were successfully deployed in all target vessels (device success 100%), while technical success was achieved in (96.8%) lesions (75% in totally occluded segments).One totally occluded segment and one restenosis were treated with surgical venous patching.There were no special requirements for the arterial access, and no surgical cutdown was needed in any patient.A contralateral access was used in 34 (53.9%) cases, with use of antegrade puncture for the ipsilateral access in 29 (46.1%) procedures.The balloon expanded completely in all patients, and no balloon waists were observed.One instance of significant vasospasm was treated with intra-arterial nitroglycerin; no dissection, thrombosis, or embolization was observed.Concomitant endovascular techniques were necessary in 27 (42.9%) procedures in the inflow (15 angioplasty + stent and 3 dilation only) or runoff vessels (9 dilation only).Stent insertion was not necessary.Debs successfully decreased the percentage of anastomotic stenosis from 70.7% before intervention to 10.9% after treatment, as evaluated by angiography.At initial duplex follow-up, all psv gradients were <(> <<)>2 cm/s.There were no differences were observed between lesions shorter or longer than 2 cm.The mean follow-up was 16.7 months (range 3¿24); 1 patient was lost to follow-up 1 month after graft revision and 3 beyond 6 months.Five anastomotic restenosis occurred at deb sites at; 4 were treated successfully with repeat deb and the other with a cutting balloon.There were 2 intragraft restenosis at 6 and 12 months; in both cases, conventional balloon dilation was performed.Five patients with severe runoff vessel disease had graft occlusion at 6 and 12 months; 2 required above-the-knee and 1 below-the-knee amputations.The limb salvage rate was 87.8%.No other patient had recurrent cli.The estimated cumulative deb site¿related primary and secondary patency rates at 6 months were 91% and 96%, respectively, and 70% and 90%, respectively, at both 12 and 18 months (there were no restenosis after 12 months).The cumulative graft patency rates for 6 and 12/18 months were 96% and 90%, respectively.The cumulative amputation-free rates at the same time points were 98% and 93%, respectively.The study concluded that debs proved to be a feasible, safe, and effective treatment for vein and prosthetic bypass graft stenosis, with excellent technical success and acceptable short and midterm patency.Journal article image review: the image show a posteroanterior digital subtraction angiograms of a common femoral to anterior tibial artery vein bypass graft (no restenosis was detected at the 18-month follow-up) and a posteroanterior digital subtraction angiograms of a common femoral to below-the-knee popliteal artery vein bypass graft.

Manufacturer Narrative

Evaluation results: inherent risk of procedure - vessel spasm.No results available since no evaluation performed- device or procedural images not provided for review.No device received for evaluation.Root cause is undetermined.Evaluation conclusion: inherent risk of procedure-vessel spasm.Unable to confirm complaint - device not provided for review.Root cause is undetermined.Article title: "percutaneous transluminal angioplasty with drug-eluting balloons for salvage of infrainguinal bypass grafts".Drug-eluting balloon in limb graft stenosis san norberto et al.Journal of endovascular therapy 2014;21:12-21.

Manufacturer Narrative

Unapproved use of device- device used in infrainguinal bypass graft.Off ¿label, unapproved or contraindicated use-device used in infrainguinal bypass grafts.

• Brand Name: IN.PACT ADMIRAL
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld 8500 ; CH 8500
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4717852
• MDR Text Key: 5746958
• Report Number: 3004066202-2015-00195
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 04/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2015
• 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: 00071 YR