MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Vascular Dissection (3160); Embolism/Embolus (4438); Restenosis (4576); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Event Description

The article reports a single-center, retrospective study of 22 consecutive patients (23 limbs) who underwent dcb angioplasty followed by des stenting for the treatment of femoropopliteal lesions.All procedures were performed according to the standards of femoropopliteal artery endovascular revascularization, via either a contralateral or an ipsilateral approach.The type of anesthesia, access site, crossing guidewires, support catheters, the type/number of dcbs used, as well as the adjuvant use of cutting balloons, employed atherectomy devices, utilization of distal filter, and/or ivl application, were at the discretion of the operator.Additionally, bail-out stenting with des occurred at the discretion of the operator in cases of severe flow-limiting dissections or suboptimal angiographic results with significant recoil and/or residual stenosis.Moreover, significant inflow and/or outflow disease were treated at the discretion of the operator.For intraprocedural anticoagulation, heparin was used, with a targeted activated clotting time of >250 seconds.Additionally, antithrombotic therapy with antiplatelet agents (eg, aspirin, clopidogrel) and/or anticoagulants wasadministered pre- and post procedurally based on the preference of the operator.Specifically, 18 patients were on dual-antiplatelet therapy (dapt) post procedure, with 3 of these 18 patients also on low-dose rivaroxaban.In the remaining patients, 3 were given low-dose aspirin or clopidogrel combined with low-dose rivaroxaban and 1 patient (deemed to be at increased risk for bleeding) was placed on aspirin monotherapy.Additionally, all but 2 patients were on moderate- or high-intensity statin therapy based on operator¿s preference post procedure.N all cases, the sfa was involved, with the disease extending into the popliteal artery in 7 cases and a mean lesion length of 321 ± 130 mm.In the majority of cases, a cto with moderate/severe calcification was present.Overall, in 9 and 4 cases, inflow and outflow disease were treated with standard endovascular recanalization techniques, respectively.Dcb angioplasty was performed with the non-medtronic dcb (philips) in 6 cases and the in.Pact admiral dcb (medtronic) in the remaining cases.Provisional stenting with des was required due to flow-limiting dissection (grade c or higher) in 10 cases and due to suboptimal angiographic result due to significant residual stenosis and/or recoil in 13 cases.Multiple non-medtronic dess were used in 8 cases.All but 1 limb was successfully revascularized with <(><<)>30% residual stenosis.The 1 procedural failure was due to a case of severely calcified sfa-cto that showed persistent mild recoil on final angiography.There were no procedural deaths, strokes, or myocardial infarctions observed.In 1 patient, distal embolization to infrapopliteal vessels occurred intraprocedurally.However, this was treated successfully with aspiration thrombectomy, with final angiography showing no residual thrombus in the run-off vessels.Additionally, 1 patient developed an access-site hematoma that was treated conservatively and resolved a few weeks post procedure.Abi improved from a mean baseline value of 0.55 ± 0.20 to a postprocedural value (within 30 days) of 0.96 ± 0.17.The mean toe-brachial index (tbi) was 0.31 ± 0.21 preprocedure and 0.75 ± 0.51 post procedure.The average follow-up was 15 ± 7 months.At 12-month follow-up, the mean abi and tbi values were 0.95 ± 0.16 and 0.77 ± 0.10, respectively.Restenosis or reocclusion of the target vessel, detected byduplex ultrasound, was o bserved in 6 cases (26.1%), although only 3 patients required revascularization (13.0%).The 6-, 12-, and 24-month rates of freedom from tlr were 90.4% (95% confidence interval [ci], 66.8-97.5), 84.8% (95% ci, 59.6-94.9), and 84.8% (95% ci, 59.6-94.9), respectively.One additional patient, with cli at baseline, underwent major amputation 7.6 months post procedure.Another patient who presented with cli at baseline also required multiple interventions and eventually severe disease progression led to limb loss and death.Additionally, 2 patients underwent coronary artery revascularization during follow-up, while 1 patient suffered a stroke 12.7 months after the index procedure.Moreover, routine duplex ultrasound during follow-up failed to show any aneurysmal formation at sites of non-medtronic stent placement (ie, sites of double paclitaxel dose).

Manufacturer Narrative

Average age, majority gender, date of publication (month/year valid) journal title - concomitant drug-coated balloon angioplasty with bail-out use of eluvia drug-eluting stent: is there any downside to a double dose of paclitaxel? issn 1557-2501 index j invasive cardiol 2022;34(6):e469-e476.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14912908
• MDR Text Key: 295248391
• Report Number: 9612164-2022-02505
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2022

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: 06/21/2022
• Initial Date FDA Received: 07/05/2022
• 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
• Patient Sex: Male
• Patient Race: White