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

Catalog Number	ADM05012013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: an image was provided for the evaluation.The image show the patient's legs with rash.The image provide confirms the event reported by the physician.
Event or Problem Description
The patient had two procedures first on (b)(6) 2017 for the right sfa, and second on (b)64) 2017 for the left sfa/popliteal.Both cases used csi orbital atherectomy followed by in.Pact admiral.Bilateral rash below the knees to the ankle occurred 3 days post second procedure.She had blisters over the anterior surface of her bilateral lower extremities with developing erythema and pain.The blisters popped and then had skin sloughing and dryness.She has continued pain which has worsened to the point that when she moves to walk or even lift her legs up it stretches the skin and has shooting pain.The patient denies chest pain, sob, abdominal pain, nausea, vomiting, diarrhoea or constipation.Patient presented to er with a red and swelled rle with severe pain.When the patient walks, she has ble leg pain, right>left.An ultrasound of her lower extremities was negative for deep venous thrombosis.The patient did receive a drug eluting stent with paclitaxel.Patient is in need of bilateral knee surgery, but not a candidate due to pad.Le duplex revealed severe disease of the right sfa, tpt and an occluded at.Patient has a mild disease at the prior left popliteal pta site and an occluded left pt.Patient has potential venous insufficiency with compression rx recommended.Leg pain is consistent with claudication.No symptoms attributable to valvular heart disease.Patient was placed on medication.
Additional 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
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6629541
• Report Number: 9612164-2017-00732
• Device Sequence Number: 1123062
• Product Code: ONU
• UDI-Device Identifier: 00643169383630
• UDI-Public: 00643169383630
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: ADM05012013P
• Device Lot Number: 0008196371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 61