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

Catalog Number VENEM12080

Device Problems Entrapment of Device (1212); Migration (4003)

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

Event Date 04/08/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).H11:section a through f - the information provided by bd represents all of 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 Description

It was reported that during an angioplasty procedure via iliac venous, the pta balloon allegedly got stuck in the stent at the time of removal.It was further reported that the stent allegedly had little migration.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the left iliac venous, the pta balloon allegedly got stuck in the stent at the time of removal.It was further reported that the stent allegedly had little migration.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the sample was not returned for evaluation.An x-ray video was provided for review.Based on the video provided it is reasonably suggested that the balloon catheter got caught on the placed stent.However, no indication for a stent misplacement or any irregularities of the placed stent could be determined, that may have caused the reported entrapment.In addition, a permanent migration of the stent could not be confirmed.Based on the information available, no deficiency of the placed stent could be verified, and the investigation is closed with inconclusive result.A definite root cause for the reported issue could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Stent deployment procedure was found to be properly addressed, e.G., the instruction for use states: "pull back the stent system until the distal and proximal stent radiopaque markers are in position so that they are distal and proximal to the target site.The second hand should be used to support the stent delivery system.Gently hold the stability sheath and maintain it straight and under tension throughout the procedure.Do not hold or touch the dark moving sheath during stent release.Regards predilation the instruction for use states: "predilation of chronic lesions with a balloon dilatation catheter is recommended." h10: d4 (expiry date: 07/2024), g3 h11: b5, h6 (method, result, conclusion) h11:section a through f - the information provided by bd represents all of 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.H3 other text : device not returned.

• Brand Name: VENOVO VENOUS STENT
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17477853
• MDR Text Key: 320573222
• Report Number: 9681442-2023-00291
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741102097
• UDI-Public: (01)00801741102097
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VENEM12080
• Device Lot Number: ANGU2536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1