MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR STENT; VASCULAR STENT SYSTEM

Catalog Number EX060603C

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent stent system products that are cleared in the us.The pro code and 510k number for the lifestent stent system products is identified.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.The investigation of the reported event is currently underway.Expiry date (04/2022).

Event Description

It was reported that during a stent placement procedure through the right hepatic vein, the device allegedly felt resistance while being inserted.It was further reported that the stent failed to reach the desired lesion.The procedure was completed by closing the collateral vessel.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.No additional complaint has been previously reported for this lot number.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.A review of manufacturing records was not performed.Investigation summary: the sample was returned to the manufacturer for evaluation.Based on the evaluation of the returned delivery system the reported problem to reach the target lesion could not be reproduced.No device deficiencies that may have contributed to the issues experienced by the customer could be identified.Potential factors that could have led or contributed to the reported event have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.The reported difficulties to advance the delivery system to the target lesion may be related to a difficult patient anatomy or challenging placement site.Inappropriate accessories used or not performed pre dilation may be contributing factors.In this case the reported indication of a tips procedure (transjugular intrahepatic portosystemic shunt) represents an off label use of the device.Based on the evaluation of the returned delivery system the reported problem to reach the target lesion could not be reproduced.No device deficiencies that may have contributed to the issues experienced by the customer could be identified.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the current labeling for this product the potential issue was found addressed.The instruction for use states: "if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used." regarding indications for use the instruction for use states: "the lifestent® vascular stent is intended for primary stenting of de-novo or restenotic lesions of the peripheral arteries." the intended use of the device during a tips procedure represents an off label use of the device.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510k number for the lifestent vascular stent products is identified in d2 and g4.H10: d4 (expiry date: 04/2022), g3.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 Description

It was reported that during a stent placement procedure through the right hepatic vein, the device allegedly felt resistance while being inserted.It was further reported that the stent failed to reach the desired lesion.The procedure was completed by closing the collateral vessel.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR STENT
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10903863
• MDR Text Key: 219529087
• Report Number: 9681442-2020-20046
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: EX060603C
• Device Lot Number: ANER0614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR