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

Model Number	VENUM16140
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One photo was provided for review.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 06/2021).
Event or Problem Description
It was reported that after stent deployment in the common iliac vein via common femoral vein access, the delivery system was allegedly caught on the introducer sheath during retraction.It was further reported that the delivery system and introducer sheath were removed together as one unit.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history records have been 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.The information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: based on the investigation of the delivery system and the image provided it was confirmed that the stent could be deployed, and that the delivery system got stuck on the introducer sheath during removal.An indication for a manufacturing related issue could not be found.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu state that a 10f introducer is required for access.The ifu further state that predilation of chronic lesions with a balloon dilatation catheter is recommended.H10: d4(expiry date 06/2021).H11: h3, h6(results, conclusion).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 that after stent deployment in the common iliac vein via common femoral vein access, the delivery system was allegedly caught on the introducer sheath during retraction.It was further reported that the delivery system and introducer sheath were removed together as one unit.There was no reported patient injury.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9195154
• Report Number: 9681442-2019-00184
• Device Sequence Number: 16657760
• Product Code: QAN
• UDI-Device Identifier: 00801741103605
• UDI-Public: (01)00801741103605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: VENUM16140
• Device Catalogue Number: VENUM16140
• Device Lot Number: ANDT1693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1