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

Catalog Number ADM05015013P

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

Patient Problem Reaction (2414)

Event Date 05/08/2017

Event Type  Injury  

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.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

The patient had two procedures first on (b)(6) 2017 for the right sfa, and second on (b)(6) 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, diarrhea or constipation.Patient presented to er with a red and swollen 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.

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: 6629516
• MDR Text Key: 77273461
• Report Number: 9612164-2017-00731
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169576339
• UDI-Public: 00643169576339
• 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,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2018
• Device Catalogue Number: ADM05015013P
• Device Lot Number: 0008082152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Date Device Manufactured: 06/02/2016
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 61