MAUDE Adverse Event Report: INVATEC SPA AMPHIRION DEEP PTA BALLOON CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problems Death (1802); Embolism (1829); Occlusion (1984)

Event Date 09/01/2016

Event Type  Death  

Manufacturer Narrative

Date of event: date of publication.Jordan m.Gutovich,marc l.Friedman,bonnie balzer journal of vascular and interventional radiology 2016 vol 27, issue no: 9 metastatic epithelioid angiosarcoma after thrombolysis of an occluded ulnar artery http://dx.Doi.Org/10.1016/j.Jvir.2016.06.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

This letter to the editor highlights the ongoing treatment received by a patient who developed a metastatic epithelioid angiosarcoma after thrombolysis of an occluded ulnar artery.It is reported that the majority of cases have occurred in patients who have undergone kidney transplantation.In most instances, patients developed metastatic disease.The aim of this article is to encourage extra precaution prior to intervening on a thrombosed av fistula in the context of prior transplant and chronic fistula dysfunction.It is reported that upon physical examination the patient showed cyanosis and mild edema of the left hand.There was no left ulnar or radial pulse and the hand was cold and pain was reported to be localized to the palm.Ultrasound revealed a chronically occluded left radial artery and acute thrombus occluding the distal left ulnar artery.Mobile thrombus was present in the antecubital portion of the brachiocephalic fistula.There was a 70% focal stenosis of the brachial artery at the antecubital fossa.The radial artery was occluded in the mid-forearm, with collateral reconstitution at the wrist and run off into the deep palmar arch.The ulnar artery demonstrated runoff in continuity up to the level of the wrist, where a fixed intraluminal filling defect occluded antegrade flow.Pta of the left brachial artery stenosis was performed using a non-mdt device, followed by catheter-directed thrombolytic therapy.This treatment was unsuccessful and tests revealed lysis of the occlusive clot in the distal ulnar artery, but also new vasospasm of the ulnar artery around the catheter system.As intra-arterial administration of nitroglycerin failed to change the angiographic appearance a non-mdt guidewire was advanced through the critical ulnar artery stenosis, over which a 3 mm x 12 cm amphiprion balloon catheter (medtronic) was passed.Pta was performed over the mid-distal ulnar artery.The final angiogram demonstrated brisk antegrade flow through the ulnar artery, with opacification of superficial and deep palmar arches and digital arteries to all 5 digits.This resulted in a strong left ulnar artery pulse was palpable and the left hand was warm, with good capillary refill.9 months following this procedure the patient presented with a painful mass in his forearm which was diagnosed as an aggressive lytic lesion of the distal radial metaphysis and a second lesion in the mid radial shaft with no known primary tumor.Biopsies performed supported the diagnosis of eas.The patient received chemotherapy but after 2 years of episodic chemotherapy, the patient developed biopsy-proven brain metastases and died.No pre-procedural findings were initially present to suggest an underlying malignancy.It is reported that the tumor may have been p resent in the av fistula and may have embolized to occlude the left ulnar artery.Angioplasty of the stenotic brachial artery and thrombolysis of the ulnar artery may have caused showering of tumor emboli that ultimately led to metastatic disease.

• Brand Name: AMPHIRION DEEP PTA BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6838401
• MDR Text Key: 84363322
• Report Number: 3004066202-2017-00093
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 09/01/2017
• 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): Death
• Patient Age: 37 YR