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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 07/18/2018
Event Type  Death  
Manufacturer Narrative
Event date is literature article published date journal article title: transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion. Cardiovasc interv. 2018;1¿7. Wileyonlinelibrary. Com journal/ccd vc 2018 wiley periodicals, inc. | 1 doi: 10. 1002/ccd. 27689 peripheral vascular disease original studies 1338 © 2018 wiley periodicals, inc. Wileyonlinelibrary. Com/journal/ccd catheter cardiovasc interv. 2018;92:1338¿1344. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Background: improved equipment and techniques have resulted in transition from surgical bypass to endovascular intervention to treat superficial femoral artery (sfa) chronic total occlusions (cto). A change in access site to radial (tra) or tibiopedal (tpa) artery for the treatment of these sfa cto has been reported. The feasibility, efficacy and safety of these two access sites for treatment of sfa cto have not been reported. The primary objective of this study was to compare the feasibility, safety and efficacy between tra, tpa and dual tra-tpa. Methods: medtronic devices used were pacific plus, pacific xtreme, and/or inpact admiral. We performed an as treated analysis of 184 sfa cto interventions in 161 patients, with symptomatic pad (peripheral artery disease) who underwent endovascular intervention for sfa cto, from 01/2014 to 09/2016 using either primary tra or tpa (operator discretion) at two institutions. Primary end point was 30-day major adverse event (mae) - death, amputation or target vessel revascularization, secondary endpoint was success of procedure. Interventions via the tpa were performed using 4/5/6 fr compatible balloons, including pacific plus/xtreme (medtronic), and inpact - up to 6 mm (medtronic). Interventions via the tra were performed using longer shaft equipment: pacific xtreme pta balloon 180cm (medtronic). Results: primary tra was used in 46 patients with 47 cto lesions. Primary tpa was used in 115 patients with 137 cto lesions. Primary crossing success rate was higher with tra compared to tpa (74% vs 54%, p 5 0. 01). Dual tra-tpa was required in 72 prior uncrossed lesions resulting in a crossing and procedural success of 99% and 96% respectively. The overall crossing and procedural success rate using either of these approaches was 99% and 98% respectively. The 30-day mae was 5% in tra arm (1 patient death and 1 limb amputation), 0% in tpa arm and 2% in dual tra-tpa arm (1 patient death). In the dual tra-tpa arm, there was one case of minor dissection (non-flow limiting) for which a stent was implanted and one case of minor thrombus formation in the popliteal artery (non-flow limiting) for which a stent was implanted. Both these cases post stent implantation showed no flow limitation or residual dissection. All access sites were patent, confirmed by ultrasound. Conclusion: the treatment of sfa cto is feasible and safe using both tra or tpa approach providing high success rates and no access site complications.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8292012
MDR Text Key134559834
Report Number9612164-2019-00367
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/10/2019
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

Patient Treatment Data
Date Received: 01/31/2019 Patient Sequence Number: 1
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