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

Catalog Number EX080403C

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that during a stent placement procedure in the left subclavian artery via the left brachial artery, the stent was positioned in the infraclavicular lesion and was released successfully after covering the lesion completely.It was further reported that after the stent was removed from the patient, the tip of the stent was allegedly found to be lost.Furthermore, radiography revealed that the tip was in the radial artery.Reportedly, an attempt was made to remove the tip, but it failed due to its inconvenient location.The current status of the patient is unknown.

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 products that are cleared in the us.The pro code and 510 k number for the lifestent 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 is currently being performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2024).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.H3 other text : device pending return.

Event Description

It was reported that during a stent placement procedure in the left subclavian artery via the left brachial artery, the stent was positioned in the infraclavicular lesion and was released successfully after covering the lesion completely.It was further reported that after the stent was removed from the patient, the tip of the stent was allegedly found to be lost.Furthermore, radiography revealed that the tip was in the radial artery.Reportedly, an attempt was made to remove the tip, but it failed due to its inconvenient location.The current status of the patient is unknown.

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 products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent 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.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 without stent that reportedly had been deployed inside patient; the oval tip of the system had been detached at the bonding joint, and was missing.Provided images demonstrate a single piece inside the patient's vessel with the shape of the oval tip.The investigation leads to confirmed result for break and detachment.Based on the investigation of the provided information, the investigation is closed as confirmed for detachment of the tip at the bonding joint.A definite root cause for the reported event could not be determined.The reported indication represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length', and 'visually confirm the delivery system integrity after removal' in regards to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques'.The instructions for use further state: 'if resistance is met during delivery system introduction, the system should be removed and another system should be used', and 'if resistance is met while retracting the stent system over a guidewire, remove the stent system and guidewire together'.The lifestent vascular stent is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and popliteal artery.H10: d4 (expiration date: 07/2024), g3, h6 (device) h11: h6 (method, result, conclusion) 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 : see h10.

• 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: 17104863
• MDR Text Key: 316931271
• Report Number: 9681442-2023-00224
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001746
• UDI-Public: (01)04049519001746
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX080403C
• Device Lot Number: ANGU3184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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
• Patient Outcome(s): Required Intervention