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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Stenosis (2263)

Event Date 04/26/2018

Event Type  Death  

Manufacturer Narrative

Age/date of birth: average age.Sex: majority gender.Date of death is literature article published date event date is literature article published date drug-coated balloon vs.Conventional balloon angioplasty in dialysis patients with symptomatic femoropopliteal disease circulation journal (2018) 82: 1908 ¿ 1916 10.1253/circj.Cj-18-0077.If information is provided in the future, a supplemental report will be issued.

Event Description

Recent randomized trials have shown the treatment benefits of use of a drug-coated balloon (dcb) over conventional percutaneous transluminal angioplasty (pta) in patients with femoropopliteal disease.However, the effectiveness and safety of dcb for dialysis patients remain unclear.Consecutive dialysis patients, who underwent pta or dcb for femoropopliteal disease, were assessed retrospectively via 2:1 propensity score matching.Effectiveness and safety endpoints, including binary restenosis, clinically driven target lesion revascularization (cd-tlr), amputations, major adverse cardiac events (mace), and deaths, were compared between groups.A total of 278 dialysis patients with 339 limbs were eligible for matching: 84 limbs from 77 patients treated with pta and 46 limbs from 37 patients treated with dcb were compared after matching.Baseline patient and lesion characteristics were not different between groups.Patients treated with dcb had significantly higher rates of freedom from binary restenosis (52.4% vs.18.6%, p<0.001) and cd-tlr (56.4% vs.25.9%, p=0.001) at 2 years compared with patients treated with pta.Both groups had similar outcomes for amputation, mace, and death.Cox proportional analysis showed that treatment with dcb was independently associated with a reduction of binary restenosis (hazard ratio [hr] 0.368, p=0.001) and cd-tlr (hr 0.390, p=0.004).This study suggested superior 2-year outcomes using dcb compared with pta and similar safety profiles in dialysis patients with femoropopliteal disease.Twenty-five (25) patients were treated using an in.Pact admiral device to convey the benefits of using a dcb over pta for femoropopliteal related diseases.In the dcb group, predilatation with an undersized, shorter, uncoated balloon was performed after crossing the lesion with a guidewire, followed by insertion of a dcb of appropriate size and length the inflation time of the dcbs was 180s using nominal pressure to allow full drug elution the mean lesion length was 198.1mm.Bailout bare-metal nitinol stents were implanted in cases of suboptimal angiographic result or flow-limiting dissection, determined by residual diameter stenosis.Following evt, aspirin was continued indefinitely in all patients.Clopidogrel was used for a minimum duration of 3 months in patients receiving nitinol stent implantation or dcb treatment.Following a 2 year follow up the rates of freedom from binary restenosis and cd-tlr (target lesion revascularization) were significantly higher in the dcb group compared with the pta group no differences were observed in the rates of freedom from mace major adverse cardiac event), minor amputation, major amputation and all-cause death between the 2 groups.It was also determined post operation administration of satins and cilostazol were negative independent factor of 2 year binary restenosis.

Manufacturer Narrative

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 ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7742900
• MDR Text Key: 115845430
• Report Number: 9612164-2018-01937
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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: 07/16/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• 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): Death
• Patient Age: 68 YR