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

Catalog Number VENEL16100

Device Problems Fracture (1260); Activation Failure (3270)

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

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, an image is provided for a review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified.(expiry date: 11/2021).

Event Description

It was reported that during the stent deployment procedure, the stent allegedly fractured and failed to expand.There was no reported patient injury.

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 returned sample could not be fully disassembled due to dried/coagulated blood but was found without indications for expansion issue or deployment failure.The provided image demonstrates the stent inside the vessel with strut irregularity in the mid section of the stent; an expansion issue was not visible.Strut irregularity/ fracture may be a subsequent event of expansion issue when the user tries to remove the system with the partially expanded stent.Therefore, the investigation confirms strut irregularity which may be a subsequent event of stent expansion issue.A definite root cause for the reported event could not be determined.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified in d2 and g4.H10: d4 (expiry date: 11/2021).H11: section a through f ¿ the information provide by bd represents all 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 Description

It was reported that during the stent deployment procedure, the stent allegedly failed to expand and fractured.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
• MDR Report Key: 11797827
• MDR Text Key: 253199558
• Report Number: 9681442-2021-00300
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: VENEL16100
• Device Lot Number: ANDY4975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR