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

Model Number	VENUL18120
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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.The investigation of the reported event is currently underway.(expiry date: 03/2021).
Event or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly failed to expand.It was further reported that the catheter was stuck on the wire and the sheath was damaged at the tip.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly failed to expand.It was further reported that the catheter was stuck on the wire and the sheath was damaged at the tip.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 sample was returned to the manufacturer for evaluation.The condition of the returned sample leads to confirmed investigation for entrapment with the introducer.The stent brake was found shifted which may have been caused by the introducer.Images were not provided so that stent foreshortening was not confirmed.A guidewire was not returned with the system, and during evaluation a system compatible guidewire could be fully inserted so that the alleged guidewire issue could not be confirmed.Potential factors that could have led or contributed to the reported event have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.Stent foreshortening may be related to incorrect holding/ handling during deployment or to interaction with the introducer sheath leading to increased friction between moving stent sheath and introducer.Use of inappropriate accessories or difficult patient condition may be contributing factors to friction increase.Stuck guidewire may be a consequence of force / friction increase leading to lumen deformation.In this case there was no reported difficulty during deployment, but the introducer reportedly was found bent which may indicate interaction with the stent brake that was found pressed over the proximal end of the tip; the size of the introducer used was not known.Based on the information available the investigation is closed with confirmed result for entrapment.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system throughout the procedure was found sufficiently described.The instruction for use state: '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.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' the instruction for use further state: 'gain femoral, popliteal or jugular access utilizing an appropriate introducer sheath.', and under materials required: '10f introducer for stent diameters of 16 mm, 18 mm and 20 mm'.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: 11559140
• Report Number: 9681442-2021-00168
• Device Sequence Number: 4881570
• Product Code: QAN
• UDI-Device Identifier: 00801741103803
• UDI-Public: (01)00801741103803
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/29/2021

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: VENUL18120
• Device Catalogue Number: VENUL18120
• Device Lot Number: ANDQ2440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 02/28/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: 74 YR
• Patient Weight: 99