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

Catalog Number 5F070801C

Device Problems Break (1069); Positioning Failure (1158); Material Separation (1562)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, safety release button allegedly broke when placing the stent.It was further reported that the stent was removed.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 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: 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, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2026).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 pending return.

Event Description

It was reported that during a stent placement procedure, the safety release button allegedly broke when placing the stent.It was further reported that the stent was 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 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 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 issues.Investigation summary: the sample was not available for evaluation.Provided images demonstrate the bloody product after the event inside a polymer bag.The inner and outer component of the safety lock slider are visibly separated.Based on the images, a closer verification is not possible so that it is not clear why the two components were separated.The investigation leads to confirmed result for break of the safety slider as reported, and the subsequent impossibility to deploy the stent.Based on the investigation of the provided information, the investigation is closed as confirmed for break of the safety slider.A definite root cause for the reported issue could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'unlock the safety lock slider by pulling it back towards the wheels from the locked position into the unlocked position.Ensure that the red safety lock slider is completely pulled back' 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.' h10: b5, d4 (expiration date: 06/2026), 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 : device not returned.

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 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 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 issues.Investigation summary: the sample was returned and the outer part of the safety slider was found separated from the inner part of the safety slider at the welding joint.Provided images demonstrate the same issue.The investigation leads to confirmed result for failure of the safety slider welding joint and the subsequent impossibility to deploy the stent.Based on the investigation of the provided information, the investigation is closed as confirmed for separation of the safety slider at the welding joint.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'unlock the safety lock slider by pulling it back towards the wheels from the locked position into the unlocked position.Ensure that the red safety lock slider is completely pulled back.', 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.Verify that the safety lock slider is still in the locked position' h10: d4 (expiration date: 06/2026), g3, h6 (device, component, result) h11: h6 (method, 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.

Event Description

It was reported that during a stent placement procedure, the safety release button allegedly broke when placing the stent.It was further reported that the stent was removed.The procedure was completed using another device.There was no reported patient injury.

• 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: 17982142
• MDR Text Key: 326508882
• Report Number: 9681442-2023-00353
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

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: 5F070801C
• Device Lot Number: ANHT0315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/21/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 02/12/2024
• Supplement Dates FDA Received: 12/13/2023; 02/22/2024
• 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