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

Model Number	VENUL16160
Medical Device Problem Codes	Malposition of Device (2616); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2022).
Event or Problem Description
It was reported that during a stent placement through femoral vein, the device allegedly failed to expand and mal-positioned.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement through femoral vein, the device allegedly failed to expand and malpositioned.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 sample 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 which was considered an indication that the stent adhered to the stent brake during deployment, which leads to a confirmed result for expansion issue.Images demonstrating stent deformation and malposition were not provided so that these subsequent issues cannot be confirmed.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instruction for use 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: 09/2022), g3.H11: h6 (results).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
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11358099
• Report Number: 9681442-2021-00053
• Device Sequence Number: 3415695
• Product Code: QAN
• UDI-Device Identifier: 00801741103681
• UDI-Public: (01)00801741103681
• 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): 03/03/2021

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: VENUL16160
• Device Catalogue Number: VENUL16160
• Device Lot Number: ANEW1536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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