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

Model Number	VENUM16040
Medical Device Problem Codes	Misfire (2532); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional 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 was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).Device pending return.
Event or Problem Description
It was reported that during deployment of the stent, the delivery system allegedly got stuck and large thumb wheel would not able to move.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 delivery system was returned 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 was considered an indication that the stent adhered to the stent brake after deployment/ upon removal.A deployment failure could not be confirmed because the stent had been released and an indication for a deployment failure could not be found on the returned sample.The provided image demonstrated stent deformation in the mid section of the short stent, which may match the issue of an expansion issue.The investigation was therefore considered an expansion issue rather than a deployment issue which leads to confirmed result for expansion issue.Based on information provided it was not entirely clear whether the reported issue was caused by a deployment issue and/or by an expansion issue.Deployment failure may be related to difficult patient anatomy or challenging placement site leading to release force increase.Inappropriate accessories or deployment without pre dilation may be contributing factors.Incorrect holding or handling during procedure may be a further contributing factor.In this case, the lesion was pre dilated, and system compatible introducer and guidewire were being used.The placement site was not known but the tracking vessel reportedly was curved.Based on the image provided, the stent was placed in a curved section.Based on the information available, 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.The instructions for use also addresses potential issues leading to release force increase leading to partial deployment/ deployment issue; the instructions for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.', and 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in regards to accessories the instructions for use state under materials required: '10f introducer for stent diameters of 16 mm, 18 mm and 20 mm ¿ 0.035 inch diameter guidewire'.Holding and handling of the system throughout the procedure including unpacking and preparation was found sufficiently described.H10: d4 (expiry date: 08/2022).H11: h6(method, result, conclusion).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 or Problem Description
It was reported that during deployment of the stent, the delivery system allegedly got stuck and large thumb wheel would not able to move.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: 11397319
• Report Number: 9681442-2021-00073
• Device Sequence Number: 1165648
• Product Code: QAN
• UDI-Device Identifier: 00801741103551
• UDI-Public: (01)00801741103551
• 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): 03/25/2021

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: VENUM16040
• Device Catalogue Number: VENUM16040
• Device Lot Number: ANEV4052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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
• Patient Age: 48 YR