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

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

Patient Problems Intimal Dissection (1333); Embolism (1829); Occlusion (1984)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: outcomes of drug-coated balloon angioplasty vs.Conventional balloon angioplasty for endovascular treatment of common femoral artery atherosclerotic disease.Journal: cardiovascular revascularization medicine year: 2020 ref: doi: 10.1016/j.Carrev.2019.11.008 1553-8389.Date of publication note: journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to investigate the safety and efficacy of drug (dcb) vs non-drug coated balloon angioplasty (ba) at the cfa segment.In this two-center study, we identified 154 patients treated either with dcb (n=47) or ba (n=107) for cfa lesions between 2006 and 2018.Hazard ratios (hr) and the respective 95% confidence interval (ci) were synthesized to examine the association between the two groups in terms of target lesion revascularization (tlr), limb loss, and major adverse limb event (male) at 12 and 24 months of follow up.This real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%).Adjunctive atherectomy was performed in 97.9% of dcb cases (n=46/47) and 44.7% of ba cases (n=51/114).The overall procedural success rate was 95%without any differences between the two groups.For standard balloon angioplasty, a non-medtronic balloon was utilized in the majority of cases.In cases where dcb were employed, either the in.Pact admiral (med tronic) or non-medtronic balloon was used, with inflation to nominal pressures for 3 min.Final angiography was performed in all cases in order to determine procedural success and the need for any bailout or further adjunctive therapies.Fluoroscopy time (dcb: 26.0 min vs ba: 33.6 min; p =.009) and contrast administration (dcb: 144.6 ml vs ba: 239.3 ml; p =.001) were less in the dcb compared to ba group.Use of a distal filter for embolic protection (dcb: 25.5% vs ba: 65.5%; p =.001) and directional atherectomy (dcb: 2.1% vs ba: 24.5%; p =.001) was more commonly utilized in the ba group, while orbital atherectomy was performed in 24 dcb cases (51.1%) and 13 ba cases (11.4%).Dissection occurred in 9.4% [dcb: 8.5% (n = 4/47) vs ba: 9.7% (n = 11/113); p =.81] ((the dissection was flow-limiting and was treated with stenting)) and distal embolization occurring in 1.2% [dcb: 82% (n = 1/47) vs ba: 0.8% (n =1/113); p =.52] of all cases respectively, with target lesion success (dcb: 100% vs ba: 95.6%; p =.147) and procedural success (dcb: 95.7% vs ba: 95.6%; p =.971) similar between the two groups., provisional stenting was more commonly necessary in ba vs dcb cases (12.3% vs 2.13%, p =.044).Most patients were discharged on dual anti-platelet therapy periprocedural (within 30 days) mean abi was improved compared to baseline values of each group (dcb: 0.8 vs 0.6 and ba: 0.7 vs 0.5), without any difference between the two groups (p =.366).Incidence of myocardial infarction (mi) (dcb: 6.4% vs ba: 6.6%; p =.959) after the endovascular therapy was similar among patients treated with dcb vs ba, while higher mortality was recorded for the ba group (dcb: 14.9% vs ba: 31.7%; p =.030) during a mean follow up of 19.3 months.The km-estimates of freedom from surgical revascularization at 1- and 2-year follow up in dcb vs ba was 97.5% vs 93.3% (hr: 0.41; 95% ci: 0.05¿3.48; p =.41) and 97.5% vs 93.3% (hr: 0.41; 95% ci: 0.05¿3.48; p =.41) respectively (i.E.All surgical revascularizations occurred within the first year after the primary procedure).Overall surgical revascularization was required in 8 cases during a mean follow up of 19.3months (dcb: 2.3%;n=1/44 vs ba: 6.9%;n=7/101; p=.26).The km-estimates of freedom from tlr at 1- and 2-year follow up in dcb vs.Ba was 89.9% vs 89.0% (hr: 0.76; 95% ci: 0.20¿2.87; p =.68) and 75.5% vs 86.8% (hr: 1.31; 95% ci: 0.46¿3.67; p =.61) respectively.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10606136
• MDR Text Key: 209170750
• Report Number: 9612164-2020-03700
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

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: 09/15/2020
• Initial Date FDA Received: 09/30/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 85