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

Model Number VENUM16140

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

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 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
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12107742
• MDR Text Key: 259653153
• Report Number: 9681442-2021-00386
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103605
• UDI-Public: (01)00801741103605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other