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

Model Number	VENUL18120
Medical Device Problem Codes	Entrapment of Device (1212); Appropriate Device Problem Term/Code Not Available (3191); Activation Failure (3270)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 01/2022).Device pending return.
Event or Problem Description
It was reported that during stent placement through iliac vein, the stent allegedly did not deploy correctly.It was further reported that the stent allegedly stuck in the iliac vein.Reportedly medical intervention was required to remove the stent.The patient current status was normal.
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 evaluation of the image and returned sample confirmed that the user experienced a deployment issue with the stent during deployment leading to interaction between stent and delivery system.The complete proximal stent end being undeployed leads to the conclusion that the issue was caused by a deployment issue.The provided image and the returned sample indicated that the stent fractured which was considered the consequence of the stent being stuck to the system upon removal.The provided image indicated a deployment issue rather than an expansion issue which led to a confirmed result for partial deployment.Based on the information available, a definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instructions for use for this product was conducted.Regarding a potential deployment failure the instructions for use states: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' and 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in addition, the instructions for use was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: d4 (expiry date: 01/2022), g3 h11: b3, h6(device, method, result, conclusion) h11: section a through f ¿ the information provide by bd represents all 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 that during stent placement procedure through iliac vein, the stent allegedly did not deploy correctly.It was further reported that the stent allegedly stuck in the iliac vein.Reportedly medical intervention was required to remove the stent.The patient current status was normal.

• Brand Name: VENOVO VENOUS STENT
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10789779
• Report Number: 9681442-2020-20025
• Device Sequence Number: 14436012
• Product Code: QAN
• UDI-Device Identifier: 00801741103803
• UDI-Public: (01)00801741103803
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: VENUL18120
• Device Catalogue Number: VENUL18120
• Device Lot Number: ANEN1102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention