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

Model Number VENUL20060

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

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending; however, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2022).The information provide by bd represents all the known information at this time.

Event Description

It was reported that during a stent placement procedure.The stent was allegedly failed to expand.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure, the stent allegedly 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 sample was returned to the manufacturer for evaluation.The condition of the returned delivery system confirmed an expansion issue.The stent brake of the inner catheter which had been under the stent during deployment was found with heavy imprints, and superficial damage which indicated that the stent adhered to the stent brake upon removal.Images provided demonstrated that the stent was visibly constricted in the area of the silicone stent brake.Distal and proximal of that section the stent was regularly expanded so that it appeared like an hour-glass which indicated that the deployment sheath had been retracted and that the stent adhered to the silicone brake.One image further confirmed strut fracture.The investigation therefore confirms expansion issue.Based upon the available information a definitive root cause could not be determined.Labeling review: a review of the relevant labeling 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: 10/2022), g3.H11: h6 (method, result).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.

• 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: 11336390
• MDR Text Key: 262200866
• Report Number: 9681442-2021-00044
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103919
• UDI-Public: (01)00801741103919
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUL20060
• Device Catalogue Number: VENUL20060
• Device Lot Number: ANEX0728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 108