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

Model Number	VENUM20080
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for evaluation; however, photo was 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 a stent placement procedure through common and external iliac vein, the stent allegedly got twisted.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure through common and external iliac vein, the stent allegedly got twisted.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history record of this lot was 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 physical sample was not available.One x-ray image was provided demonstrating the stent after the event.Minor irregularity was visible on the stent but twisting or expansion issue could not be identified.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the minor irregularity the issue was considered rather an expansion issue than a stent twisting.Note that expansion issue caused by stent getting stuck on inner catheter may appear like a stent twisting on x-ray.A definitive root cause could not be determined based upon the available information.Labeling review: a review of the relevant instructions for use for this product was conducted.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: 07/2022).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.H3 other text : device not returned.

• 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: 11432212
• Report Number: 9681442-2021-00122
• Device Sequence Number: 14274558
• Product Code: QAN
• UDI-Device Identifier: 00801741103858
• UDI-Public: (01)00801741103858
• 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): 07/02/2021

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: VENUM20080
• Device Catalogue Number: VENUM20080
• Device Lot Number: ANEU3302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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