MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Unspecified Infection (1930); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the evercross pta balloon catheter.Survey results received for a cardiovascular surgeon practicing in (b)(6) who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (11 procedures), femoral arteries (5 procedures), ilio-femoral arteries (12 procedures), popliteal arteries (9 procedures), infra-popliteal arteries (13 procedures), and renal arteries (7 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (10 procedures) and for stent post dilatation in the peripheral vasculature (7 procedures).This cardiovascular surgeon also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (8 procedures), femoral arteries (6 procedures), ilio-femoral arteries (11 procedures), popliteal arteries (8 procedures), infra-popliteal arteries (13 procedures), and renal arteries (8 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (9 procedures) and for stent post dilatation in the peripheral vasculature (12 procedures).Related to the evercross pta balloon catheter, one bleeding requiring transfusion event is reported during dilatation of stenoses in the iliac arteries.One infection event is reported during dilatation of stenoses in the ilio-femoral arteries.Both of these events are reported to be somewhat concerning and device related.Immediate acute bleeding is reported for the bleeding event requiring transfusion.The infection is described as puncture wound exudate.Related to the fortrex pta balloon catheter, one fever event is reported during dilatation of stenoses in the femoral arteries, and during treatment of obstructive lesions of nat ive or synthetic arteriovenous dialysis fistulae.One hematoma event is reported during dilatation of stenoses in the iliac arteries, ilio-femoral arteries, popliteal arteries, renal arteries, as well as during stent post dilatation in the peripheral vasculature.One intraluminal thrombus event is reported during dilatation of stenoses in the infra-popliteal arteries.The fever event was reported to be somewhat concerning and device related.The fever event occurred less than 24 hours post treatment.The hematoma event (large superficial hematoma) and intraluminal thrombus event are reported to be not at all concerning.The hematoma event is reported to be device related also.The intraluminal thrombus is reported to not be device related.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9009940
• MDR Text Key: 162332521
• Report Number: 2183870-2019-00445
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• 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