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

Model Number	VENUM14100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Positioning Failure (1158); Malposition of Device (2616); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2022).
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly did not deploy fully and stuck on the proximal portion.Further reported that the physician removed the retracting catheter from the body, the stent jumped forward about 2 cms.The procedure was completed using another device.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 returned delivery system was found with loaded stent and with activated wheel but with loose joint slide block/ diving sheath which confirmed that a deployment was impossible.Based on the information available the reported impossibility to deploy the stent due to a force transmitting joint becoming loose was confirmed.Potential factors that could have led or contributed to the event reported have been evaluated.Therefore, previous investigations of similar complaints were reviewed.In this case a force transmitting joint was confirmed being loose, which caused the reported impossibility to deploy the stent.Based upon the available information a definitive root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit." 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 a stent placement procedure, the stent allegedly did not deploy fully and stuck on the proximal portion.Further reported that the physician removed the retracting catheter from the body, the stent jumped forward about 2 cms.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly did not deploy fully and stuck on the proximal portion.Further reported that the physician removed the retracting catheter from the body, the stent jumped forward about 2 cms.The procedure was completed using another device.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 to the manufacturer for evaluation.The returned delivery system was found with loaded stent and with activated wheel but with loose joint slide block/ diving sheath which confirmed that a deployment was impossible.A force transmitting joint was confirmed being loose, which caused the reported impossibility to deploy the stent.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit." h10: d4 (expiry date: 11/2022).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: 11408713
• Report Number: 9681442-2021-00113
• Device Sequence Number: 17051834
• Product Code: QAN
• UDI-Device Identifier: 00801741103445
• UDI-Public: (01)00801741103445
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/08/2021

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: VENUM14100
• Device Catalogue Number: VENUM14100
• Device Lot Number: ANEY2061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 07/07/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/12/2021; 08/05/2021
• 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