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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT SYSTEM; VASCULAR STENT

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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT SYSTEM; VASCULAR STENT Back to Search Results
Catalog Number UNK VENOVO VENOUS STENT SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Hematuria (2558)
Event Date 06/21/2018
Event Type  Injury  
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified.As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: rodriguez-morata, a., robles-martin, m.L., & reyes-ortega, j.P.(2019).Endovascular treatment of posterior nutcracker syndrome with a new autoexpandable stent.Journal of vascular surgery: venous and lymphatic disorders, 7(1), 118¿121.Doi: 10.1016/j.Jvsv.2018.06.008.
 
Event Description
It was reported in an article from the journal of vascular surgery: venous and lymphatic disorders titled " endovascular treatment of posterior nutcracker syndrome with a new autoexpandable stent " that two cases with a posterior nutcracker syndrome (pns) were treated with a stenting of the left renal vein via a complete endovascular approach.In the immediate postoperative period, both patients had back pain at the dorsal lumbar level and the medical treatment has been acetylsalicylic acid at low doses.This pain approximately lasted for 3 weeks.At 17-month follow-up for case one and 9-month follow-up for case two, the patients were clinically well and asymptomatic.The postoperative back pain in the early postoperative period is due to the pressure of the self-expanding stent on the spine.
 
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Brand Name
VENOVO VENOUS STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9344778
MDR Text Key168100880
Report Number9681442-2019-00233
Device Sequence Number1
Product Code QAN
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P180037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/19/2019
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK VENOVO VENOUS STENT SYSTEM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/29/2019
Initial Date FDA Received11/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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