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

Catalog Number EX072003JL

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Material Deformation (2976); Positioning Problem (3009)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure of a highly calcified target lesion in the left common femoral artery and the superficial femoral artery via a contralateral approach, the catheter was allegedly hard to cross the bifurcation and the calcified lesion.The device could reach the lesion with strong force.However, the trigger was so hard that the stent could not be deployed.It was further reported that the shaft of the catheter was allegedly found kinked upon retrieval.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 04/2023).H11: section a through f ¿ the information provided 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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement procedure of a highly calcified target lesion in the left common femoral artery and the superficial femoral artery via a contralateral approach, the catheter was allegedly hard to cross the bifurcation and the calcified lesion.The device could reach the lesion with strong force.However, the trigger was so hard that the stent could not be deployed.It was further reported that the shaft of the catheter was allegedly found kinked upon retrieval.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

The file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent products are identified in d2 and g4.D4 (expiration date: 04/2023).H11: section a through f ¿ the information provided 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.Device not returned.

• Brand Name: LIFESTENT SOLO VASCULAR STENT
• Type of Device: VASCULAR 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: 16825703
• MDR Text Key: 314116734
• Report Number: 9681442-2023-00167
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112058
• UDI-Public: (01)00801741112058
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070014
• 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: 06/23/2023

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: EX072003JL
• Device Lot Number: ANFR2486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 06/27/2023
• 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
• Patient Sex: Female