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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNK-CV-GWY-PCF
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Occlusion (1984); Vascular Dissection (3160)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During index procedure, three in. Pact 014 paclitaxel eluting balloon catheters were used to treat the anterior tibial artery (ata). During procedure dissection occurred and was treated with the implantation of three integrity bare metal stents. A revascularization was carried using a pacific xtreme pta balloon. Approximately 7 months post index procedure and 4 months post revascularization, patient suffered critical limb ischemia to the right limb. Revascularization was carried out using a non-medtronic pta balloon in the right anterior tibial artery (target vessel). Patient recovered. Investigator and sponsor assessed event is not related to the device, procedure or paclitaxel.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Sponsor assessed event as causally related to the index device and procedure, but not related to paclitaxel. Cec assessed event as causally related to the index device and procedure but not related to paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, 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 Key7731020
MDR Text Key115366607
Report Number9612164-2018-01887
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-PCF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
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

Patient Treatment Data
Date Received: 07/30/2018 Patient Sequence Number: 1
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