MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number 5F061501C

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure of a chronic total occlusion in the superficial femoral artery via a contralateral approach, the catheter was allegedly unable to be advanced at the bifurcation site.The catheter was found kinked and bunched upon removal.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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: 03/2024).Device pending return.

Event Description

It was reported that during a stent placement procedure of a chronic total occlusion in the superficial femoral artery via a contralateral approach, the catheter was allegedly unable to be advanced at the bifurcation site.The catheter was found kinked and bunched upon removal.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 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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, no photos were provided for evaluation.Based on the investigation of the provided information, the investigation is closed as inconclusive.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.The ifu state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'keep the device as straight as possible following removal from the packaging and while inserted in the patient.' in regards to access and accessories the ifu state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.(.) insert a guidewire of (.) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter'.Furtherly, the ifu state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.', and 'examine the stent system to ensure it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.', and 'it is recommended to use the 80 cm working length device for ipsilateral procedures.' h10: d4 (expiry date: 03/2024).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.H3 other text : device not returned.

• Brand Name: LIFESTENT 5F 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: 16530267
• MDR Text Key: 311382617
• Report Number: 9681442-2023-00076
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120022
• UDI-Public: (01)00801741120022
• 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: 04/18/2023

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: 5F061501C
• Device Lot Number: ANFQ3098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/24/2023
• 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