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

Catalog Number AB35W10040135

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

Patient Problem Stenosis (2263)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, a medtronic standard pta was used to treat the right cephalic arch and a medtronic balloon was also used for post dilation.Approximately 14.5 months post index procedure patient suffered cephalic vein stenosis in avf.The same day, event was treated with non medtronic pta of venous outflow and medication.Investigator and sponsor assessed the event as not related to the index device or antiplatelet medication.Patient recovered.Cec adjudicated revascularization is not clinically driven, this is a target lesion revasc.Cec also adjudicated event is related to device but not related to procedure or therapy.

Manufacturer Narrative

Additional information: patient is a former smoker with a medical history of hypertension, hyperlipidemia, diabetes, renal insufficiency, coronary heart disease, congestive heart failure, peripheral artery disease and previous pta of the cephalic arch.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported that an admiral 7x80 balloon was used during the index procedure.No lot details recorded.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was reported that an evercross pta balloon (10x40mm) was used to post dilate lesion during index procedure.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): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8573546
• MDR Text Key: 143832108
• Report Number: 9612164-2019-01569
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AB35W10040135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR