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

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

Patient Problem Thrombus (2101)

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 vascular 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 (2 procedures), femoral arteries (6 procedures), ilio-femoral arteries (3 procedures), popliteal arteries (8 procedures) and infra-popliteal arteries (10 procedures). The evercross pta balloon catheter was also used during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (3 procedures) and for stent post dilatation in the peripheral vasculature (6 procedures). A contrast media reaction/renal failure event is reported during dilatation of stenoses in the femoral arteries. A hematoma event is reported during dilatation of stenoses in the popliteal arteries, and infra-popliteal arteries. Intraluminal thrombus is reported to have occurred during dilatation of stenoses in the infra-popliteal arteries and during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. 2 occurrences of each complication/adverse event have been reported. The contrast media reaction/renal failure and intraluminal thrombus events a reported to be somewhat concerning. The hematoma event is reported to be not at all concerning. Both the contrast media reaction/renal failure, and hematoma events are reported to have not been device related at all. One of the intraluminal thrombus events is reported to have been device related but is reported have been absorbed spontaneously.

Manufacturer Narrative

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

• 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: 9008935
• MDR Text Key: 161381052
• Report Number: 2183870-2019-00440
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial