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

Model Number	VENUM14060
Medical Device Problem Codes	Misfire (2532); Malposition of Device (2616); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image is provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).
Event or Problem Description
It was reported that during treatment, the stent allegedly was stuck to the deployment system after successful release.The stent finally expanded after few minutes.There was no reported patient injury.
Event or Problem Description
It was reported that during stent placement in the iliac vein the stent allegedly was stuck to the deployment system after release leading to expansion issue and malposition.The stent finally successfully expanded after a few minutes by pulling.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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 returned sample, and images provided confirmed that the user experienced an expansion issue with the stent during deployment.Shifting of the inner catheter stent brake on the returned sample, and hourglass like deformation near the stent brake section indicated that the stent adhered to the stent brake during deployment, leading to expansion issue.As reported, the stent did finally expand successfully after a few minutes.Malposition could not be confirmed based on the image provided.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant for this product was conducted.The instruction 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: 07/2022).H11: h6 (results).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.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10873398
• Report Number: 9681442-2020-20038
• Device Sequence Number: 2863638
• Product Code: QAN
• UDI-Device Identifier: 00801741103421
• UDI-Public: (01)00801741103421
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: Health Professional
• Device Model Number: VENUM14060
• Device Catalogue Number: VENUM14060
• Device Lot Number: ANEU4241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 02/21/2021
• 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: Other