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

Model Number	VENUM16140
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device was returned for evaluation.The returned sample was investigated, and the loaded stent length was found within specification.Therefore, the investigation is unconfirmed for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use states: 'measure the length of the target lesion to identify the appropriate length of stent(s) required.Ensure that the stent is long enough to permit the area proximal and distal of the lesion to be covered by the stent.The stent dimensions listed in table 1 include the smallest and largest stent sizes offered.The results provided are indicative of the foreshortening for the entire stent size matrix.' table 1 states for the 16 diameter stent a max.Foreshortening of 3-5%.(expiry date: 08/2022).
Event or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly too long for the lesion to be placed.It was further reported that the stent was not deployed and another stent was used to complete the procedure.There was no reported patient injury.

• 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: 12107742
• Report Number: 9681442-2021-00386
• Device Sequence Number: 3704348
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: VENUM16140
• Device Catalogue Number: VENUM16140
• Device Lot Number: ANEV1748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/02/2021
• 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