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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKPOWERFLEXPRO CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION UNKPOWERFLEXPRO CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNKPOWERFLEXPRO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
This is a complaint that was discovered during a literature search. Additional information to include from (b)(6). The product was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
After a powerflex pro was used, multiple dissections of the superficial femoral artery (sfa) was noted. Thus, the sfa was stented from the origin to the suprageniculate popliteal artery with two 6- x 100 mm and one 6- x 120 mm smart flex vascular stent systems. The patient was discharged the next day. A patient was admitted to the vascular surgery unit for 6 months of critical limb ischemia (cli) of the left lower limb. Computed tomography angiography (cta) showed a 25 cm long occlusion of the left sfa from its origin to the adductor canal, with a patent popliteal artery and occlusion of the anterior tibial artery at the proximal third. The patient was treated endovascularly via percutaneous retrograde right femoral artery access. A 6f x 45-cm non cordis introducer sheath was inserted and placed in the left common femoral artery. Control angiography confirmed the occlusion of the sfa with distal reperfusion at the level of the adductor canal. The sfa was reopened subintimal; after reentry into the lumen, the length of the sfa was treated with angioplasty 6- x 100-mm powerflex pro pta catheter. Angiography revealed post-angioplasty recoil and multiple dissections hindering the blood flow. Thus, the sfa was stented from the origin to the suprageniculate popliteal artery with two 6- x 100 mm and one 6- x 120 mm smart flex vascular stent systems. The final angiographic control showed direct flow to the distal posterior tibial artery. The post-procedural course was uncomplicated, and the patient was discharged on first postoperative day with resolution of cli. Follow-up at 3 and 6 months showed patency of the femoropopliteal axis with no complications such as stent fracture, displacement, buckling, or in-stent restenosis.
 
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Brand NameUNKPOWERFLEXPRO
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7527065
MDR Text Key108723656
Report Number9616099-2018-02138
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKPOWERFLEXPRO
Device Catalogue NumberUNKPOWERFLEXPRO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/19/2018
Event Location No Information
Date Manufacturer Received07/20/2018
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: 05/18/2018 Patient Sequence Number: 1
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