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 Unspecified Infection (1930); Reaction (2414)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

Article title: acute hypersensitivity reaction to femoral drug-coated balloons edward lake, michael twigg, and finn farquharson central manchester university hospitals nhs foundation trust, manchester, united kingdom vasa (2017), 46 (3), 223¿225 https://doi.Org/10.1024/0301-1526/a000604 © 2017 hogrefe.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

Patient was admitted with critical ischaemia of the right foot with rest pain and infected non-healing ulceration.An arterial duplex revealed triphasic femoral waveforms and monophasic popliteal waveforms in the right leg, indicative of a distal sfa to proximal popliteal artery stenosis.On examination, the patient had severe circumferential infected ulceration to the right lower leg and dorsum of the foot.There were no rashes or cellulitis above the knee.The patient underwent a distal sfa and proximal popliteal artery angioplasty.A 6f sheath was inserted following antegrade common femoral puncture.Angiogram confirmed a stenotic segment in the distal sfa, correlating with the region of previous angioplasty.There was single vessel run-off into the foot via the anterior tibial artery, with an incomplete plantar arch and occluded posterior tibial artery.Angioplasty of the fa/popliteal stenosis was performed using a 5 x120 mm in.Pact admiral drug coated balloon.Balloon inflation time was one minute.A completion angiogram showed a satisfactory angiographic result of the treated segment.Within a minute of removing the balloon, the patient complained of severe pain in their right thigh, and became extremely agitated.Patient became tachycardic at a rate of 175 bpm, and hypertensive at 180/106 mmhg.An erythematous rash quickly developed in the right lower thigh directly over the region that had been angioplastied.The foot remained warm and well perfused.10 mg of morphine analgesia was administered, along with oxygen via a facemask, and 100 mg intravenous hydrocortisone as well as 10 mg intravenous chlorphenamine.There was no generalised rash, angioedema or breathing difficulty.The area of erythema to the thigh was marked.The patient remained in significant pain in the thigh, and also developed some pain in the foot, requiring further doses of morphine.The rash to the thigh reduced over the subsequent 48 hours.Unfortunately the infection in the leg continued to deteriorate and the patient required right above knee amputation, which healed well and gave significant pain relief.

• 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: 6688893
• MDR Text Key: 79118811
• Report Number: 9612164-2017-00858
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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: 06/07/2017
• 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: 71 YR