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

Catalog Number EX080403C

Device Problems Positioning Failure (1158); Self-Activation or Keying (1557); Device-Device Incompatibility (2919)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, when the guide wire reached the lesion site, the stent was attempted to pass through the guide wire to the lesion for release, but allegedly failed.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 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 catheter sample was found with correctly locked shipping lock, with unused deployment mechanism, and the stent was 1mm prematurely deployed but not flowered.During evaluation testing a system compatible 0.035" guidewire could not be inserted after successful flushing because it got stuck in the grip section.The investigation leads to confirmed result for stuck guidewire and cascading self activation.Based on the investigation of the provided information, the investigation is closed as confirmed for stuck guidewire, and subsequent self activation.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 instruction for use state: 'advance the device over the 0.035 inch (0.89 mm) diameter guidewire through the sheath introducer.(.) if resistance is met during delivery system introduction, the system should be removed and another system should be used.' the instruction for use further state: 'flush the inner lumen of the device with normal, sterile saline prior to use.', and 'visually inspect the distal end of the delivery system catheter to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.' h10: d4 (expiry date: 07/2024).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: 17689341
• MDR Text Key: 322703563
• Report Number: 9681442-2023-00318
• 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
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• 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
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• 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