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 Embolism (1829); Reaction (2414)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Event date: date article was published.Article title: downstream panniculitis secondary to drug-eluting balloon angioplasty a c c : cardi o v a sc u lar int e rvent ions vol.9 , n o.1 7 , 2 0 1 6 ª 2 0 1 6 b y t he am e r i c an c o ll ege of car d iology foundat ion i s sn 1 9 3 6 - 8 7 9 8 / $ 3 6.0 0 p ub l i shed b y e l s e v i e r h t t p : / / d x.D o i.O r g / 1 0.1 01 6 / j.J c i n.2 0 1 6.0 6.0 1 7.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Examination revealed absent popliteal and pedal pulses in the symptomatic leg and an ankle-brachial pressure index of 0.44.Magnetic resonance angiography revealed thrombotic occlusion of the bypass graft and multiple subsequent stenoses.The patient underwent endovascular mechanical thrombectomy of the bypass graft plus angioplasty of the distal bypass anastomosis and popliteal artery using 2 paclitaxel-eluting balloons (in.Pact admiral, (b)(4)) two weeks later, the patient developed a painful rash completely restricted to her left lower limb.She consulted numerous physicians, but no diagnosis could be made.Three months later, she visited our outpatient clinic for a regular follow-up, still presenting with the localized rash, whereupon skin biopsy yielded a diagnosis of panniculitis.With oral steroid treatment, the rash gradually resolved after 3 months.In view of the histologic findings, the regional distribution of the rash and the temporal relationship to the procedure, this reaction is compatible with panniculitis secondary to particle embolization of the drug-eluting balloon coating, including paclitaxel and urea components.This adverse event should be considered due to the widespread application of drug-eluting balloons.

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: 5986203
• MDR Text Key: 55873745
• Report Number: 9612164-2016-01009
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140010
• 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: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• 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: 08/30/2016
• 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: 72 YR