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

Model Number	VENUM16040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Swelling/ Edema (4577)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will 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.Expiry date: 11/2018.
Event or Problem Description
It was reported through the results of a clinical trial that same day post index procedure, the subject developed bleeding and swelling of left groin at puncture site.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation and image was not provided for review.In this case, the patient got out of bed despite strict advice to remain in bed.A product deficiency related issue to the bleeding was not reported.The stent was successfully placed without periprocedural complication without device deficiency.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'remove the guidewire and introducer sheath from the body.Close entry wound as appropriate.' h10: d4 (expiry date: 11/2018), g3.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.
Event or Problem Description
It was reported through the results of a clinical trial that same day post index procedure, the patient developed bleeding and swelling of left groin at puncture site.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The current patient status was not provided.

• Brand Name: VENOVO VENOUS STENT
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12369616
• Report Number: 9681442-2021-00460
• Device Sequence Number: 19143712
• Product Code: QAN
• UDI-Device Identifier: 00801741103551
• UDI-Public: (01)00801741103551
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: AS
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: VENUM16040
• Device Catalogue Number: VENUM16040
• Device Lot Number: ANAY1696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN, APIXABAN; ASPIRIN, APIXABAN; ENOXAPARIN AND RIVAROXABAN; ENOXAPARIN AND RIVAROXABAN; ASPIRIN, APIXABAN; ENOXAPARIN AND RIVAROXABAN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White