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

Catalog Number EX080401C

Device Problems Loss of or Failure to Bond (1068); Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent are identified in d2 and g4.H10: 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, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2024).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.

Event Description

It was reported that during a stent placement procedure, the delivery system allegedly had resistance upon removal.It was further reported that sheath allegedly came off from the delivery system when removed.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 us but is similar to the lifestent vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 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 returned for evaluation.The returned sample was found in used condition with deployed stent that reportedly had been deployed inside patient.The guidewire lumen was found broken at the distal end, and a series of pin holes was found at the break site; the origin of the pin holes was not known.The distal end of the guidewire lumen including tip was part of the sample return.In addition, the guidewire lumen was loose from the metal hypotube inside grip and residuals of adhesive were found on the surface.Provided images match the condition of the returned sample.The investigation leads to confirmed result for break, and detachment of the guidewire lumen including failure of a bond joint.The vessel was not tortuous but calcified; the lesion was pre dilated, and a system compatible 0.035" guidewire was in use.The user could successfully flush the system before use.Based on the investigation of the provided information, the investigation is closed as confirmed for break and detachment of the guidewire lumen.A definite root cause for the reported event could not be determined.Deployment in the iliac artery represents off label use.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'if resistance is met while retracting the stent system over a guidewire, remove the stent system and guidewire together.Visually confirm the delivery system integrity after removal.' the instruction for use further state: 'predilation of the lesion should be performed using standard techniques.' under required materials the instruction for use state: '6f (2.0 mm) or larger introducer sheath (.) 0.035 inch (0.89 mm) diameter guidewire'.The lifestent vascular stent is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and popliteal artery.H10: b5, d4 (expiration date: 01/2024), g3, h6 (device).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.

Event Description

It was reported that during a stent placement procedure in the right external iliac artery via the right common femoral artery access, the delivery system allegedly had resistance upon removal.It was further reported that sheath allegedly came off from the delivery system when removed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 17196166
• MDR Text Key: 318028823
• Report Number: 9681442-2023-00243
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001739
• UDI-Public: (01)04049519001739
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX080401C
• Device Lot Number: ANGN2149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• 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