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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT Back to Search Results
Catalog Number UNK VENOVO VENOUS STENT SYSTEM
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Embolism/Embolus (4438)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
 
Event Description
It was reported that post stent placement procedure, the patient allegedly experienced flank pain and a ct scan showed that the stent allegedly had migrated to the heart.It was further reported that the stent was embolized to the right atrium and right ventricle and to the pulmonary artery.Reportedly an attempt was made to remove the embolized stent fragments which was successful.Still there was a small amount of stent fragment retained in a distal sub segmental branch of the pulmonary artery in the left lower lobe and in the trabecula of the right ventricle.The current status of the patient is unknown.
 
Event Description
It was reported that post stent placement procedure, the patient allegedly experienced flank pain and a ct scan showed that the stent allegedly had migrated to the heart.It was further reported that the stent was embolized to the right atrium and right ventricle and to the pulmonary artery.Reportedly an attempt was made to remove the embolized stent fragments which was successful.Still there was a small amount of stent fragment retained in a distal sub segmental branch of the pulmonary artery in the left lower lobe and in the trabecula of the right ventricle.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not returned for evaluation and image was not provided for review.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use includes a stent size selection table describing the relationship between reference vessel diameter and unconstrained stent inner diameter.Stent migration was found addressed as a potential complication / adverse event.The venovo venous stent system is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.In regards to pta the instructions for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.', and 'post stent expansion with a balloon dilatation catheter is recommended.' h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
VENOVO VENOUS STENT
Type of Device
VENOUS STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key12108579
MDR Text Key259706845
Report Number9681442-2021-00388
Device Sequence Number1
Product Code QAN
Combination Product (y/n)N
PMA/PMN Number
P180037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
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
Date Manufacturer Received10/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
Patient Age34 YR
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