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 Stroke/CVA (1770); Embolism (1829)

Event Date 01/01/2003

Event Type  Injury  

Manufacturer Narrative

Images:the images attached in the journal article showed a peripheral artery disease with critical hand ischemia.From the few images returned it was not possible to find additional info about amphirion deep used.The adverse event reported it no not directly connected to the amphirion deep use.No malfunction of the device reported.Outcomes of endovascular therapy for upper extremity peripheral artery disease with critical hand ischemia tomoi y., soga y., fujihara m., iida o., shintani y., zen k., ando k.J.Endovasc.Ther.2016 23:5 (717-722) doi: 10.1177/1526602816659279.

Event Description

A study was carried out between january 2003 and december 2013 to determine the outcomes of endovascular therapy for upper extremity peripheral artery disease with critical hand ischemia.37 cardiovascular centers were included in the study.The analysis included 36 consecutive patients (mean age 65.7±10.3 years; 19 men) who underwent evt for de novo atherosclerotic pad in 40 upper limbs with chi.Patient baseline characteristics were hypertension, nonambulatory status, diabetes, hemodialysis, hyperlipidemia, smoking, chronic kidney disease, cerebrovascular disease, coronary <(>&<)> peripheral artery disease, heart failure, lower limb amputation, symptoms of rest pain, nonhealing ulcers and gangrene.The interosseous artery was patent in all patients, and 18 patients had isolated below-the-elbow disease.13 patients had an ipsilateral hemodialysis shunt.Stenosis was 94.1%±8.8%.During study, an amphirion deep balloon was used to dilate lesion for at least 2 minutes.It is unknown how many procedures involved an amphirion deep balloon.After pre-dilation some lesions received stents however upper limb lesions had balloon angioplasty alone.Thirty days post-procedure distal embolism and stroke were reported as patient complications.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6410674
• MDR Text Key: 70120036
• Report Number: 3004066202-2017-00036
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• 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: 02/15/2017
• 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): Hospitalization
• Patient Age: 66 YR