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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: date of article. Publication transradial versus tibiopedal access approach for endovascular intervention of superficial femoral artery chronic total occlusion. Catheter cardiovasc interv. 2018;92:1338¿1344 doi: 10. 1002/ccd. 27689. 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. Event description: 161 patients were treated (1/2014) to (9/2016), for cto in the superficial femoral artery. The patients were treated with a pacific xtreme balloon, pacific plus balloon, inpact admiral dcb balloon, inpact pacific dcb balloon, everflex entrust se stent, complete se stent, chocolate balloon and non-medtronic devices. The patients have a history of pad, cad, hypertension, hyperlipidemia, tobacco use and diabetes. It was reported the physician was unable to cross the lesion, patients presented with 3 flow limiting dissections treated with stenting, arterial perforations, bleeding hematomas, distal embolization, tvr, 1 thrombus formation in the popliteal artery, treated with stenting, 1 limb amputation, cerebrovascular accident and 2 deaths. Methods: we performed an as treated analysis of 184 sfa cto interventions in 161 patients from 01/2014 to 09/2016 using either prima ry 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. 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%, p50. 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, 0% in tpa arm and 2% in dual tra-tpa arm, p50. 08. 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. Devices reported in the article are inpact admiral, pacific xtreme, pacific plus, chocolate, complete se, everflex entrust.
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Manufacturer (Section D)
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key8657526
MDR Text Key146623971
Report Number2183870-2019-00320
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
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 Received05/13/2019
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: 05/31/2019 Patient Sequence Number: 1