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

Catalog Number 5F050603C

Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976); Positioning Problem (3009)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified in common device name and pma/510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.Expiration date: 12/2024.

Event Description

It was reported that during a stent placement procedure in the left common femoral via cross over approach, the stent allegedly could not cross the bifurcation.It was further reported that the shaft was broken.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products 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.Investigation summary: the physical sample was returned for evaluation.The returned sample was found locked with unused deployment mechanism and with a catheter break in the mid section of the delivery system; the system was not broken apart and was held by the metal filaments of the braiding layer of the proximal sheath.A damage of the proximal sheath like a dent was found further distal.Superficial deformation of the stent sheath indicates that the system was in a tight bending condition.An image was provided demonstrating an undeployed stent, which solely is not enough to confirm crossing difficulty, however, the provided information in combination with the damage found lead to confirmed result for crossing difficulty and break / deformation, but it was not known which failure occurred first.A 6f introducer with a 0.035" guidewire were used for access; the vessel was not tortuous/ not calcified, and pre dilation was not performed.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter break/ deformation, and failure to cross.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 state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' the instructions for use further state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath (.) insert a guidewire of appropriate length (table 2) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.' in regards to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' in regards to damage the instructions for use state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used'.H10: d4 (expiry date: 12/2024), g3, h6 (device).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 a stent placement procedure in the left common femoral via cross over approach, the stent allegedly could not cross the bifurcation.It was further reported that the shaft was broken.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in the left common femoral via cross over approach, the stent allegedly could not cross the bifurcation.It was further reported that the shaft was broken.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products 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.Investigation summary: the physical sample was returned for evaluation.The returned sample was found locked with unused deployment mechanism and with a catheter break in the mid section of the delivery system; the system was not broken apart and was held by the metal filaments of the braiding layer of the proximal sheath.A damage of the proximal sheath like a dent was found further distal.Superficial deformation of the stent sheath indicates that the system was in a tight bending condition.An image was provided demonstrating an undeployed stent, which solely is not enough to confirm crossing difficulty, however, the provided information in combination with the damage found lead to confirmed result for crossing difficulty and break / deformation, but it was not known which failure occurred first.A 6f introducer with a 0.035" guidewire were used for access; the vessel was not tortuous/ not calcified, and pre dilation was not performed.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter break/ deformation, and failure to cross.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 state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' the instructions for use further state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath (.) insert a guidewire of appropriate length (table 2) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.' in regards to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' in regards to damage the instructions for use state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used'.H10: d4 (expiry date: 12/2024), g3, h6 (device).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 : see h10.

• 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: 15390804
• MDR Text Key: 305498692
• Report Number: 9681442-2022-00273
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119897
• UDI-Public: (01)00801741119897
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F050603C
• Device Lot Number: ANFZ3183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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