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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W07040135
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 12/14/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During index procedure, a medtronic standard pta was used to treat the left venous outflow.Approximately 12 months post procedure, patient suffered restenosis of the proximal cephalic vein outflow and the venous outflow was treated with a medtronic standard pta balloon same day.The patient recovered.The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel.
 
Manufacturer Narrative
A stent was also implanted during index procedure to treat persistent residual stenosis.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the devices used during the index procedure were an evercross balloon and an everflex stent.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
EVERCROSS 035
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway 22570
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8849692
MDR Text Key152895396
Report Number9612164-2019-03165
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/22/2019
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
Device Expiration Date11/06/2020
Device Catalogue NumberAB35W07040135
Device Lot NumberA552368
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/16/2019
Initial Date FDA Received08/01/2019
Supplement Dates Manufacturer Received07/16/2019
09/25/2019
Supplement Dates FDA Received08/01/2019
10/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
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