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

Catalog Number EX060803C

Device Problems Break (1069); Positioning Failure (1158)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in the superficial femoral artery via the left femoral artery, the stent allegedly could not be released.The procedure was completed by 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 system products that are cleared in the us.The pro code and 510 k number for the lifestent 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 for evaluation.The returned sample was found with activated mechanism, and with loaded stent.A force transmitting component was found broken inside grip which made a successful deployment using trigger and wheel impossible.During testing, the stent could be easily deployed using the rapid deployment ring.The investigation leads to confirmed result for break, and deployment failure.Also, video clips were provided demonstrating that the stent could not be deployed using thumbslider and wheel.The vessel was not tortuous/ calcified, the lesion was pre dilated, and 6f sheath with 0.018" guidewire were used for access.Based on the investigation of the provided information, the investigation is closed as confirmed for break of a force transmitting component inside grip and subsequent deployment failure.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.Holding and handling of the system during deployment was found sufficiently described; in particular the instruction for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.(.) if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.' regarding accessories/ access the instruction 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 (.)'.The instruction for use further state: 'predilation of the lesion should be performed using standard techniques.' h10: d4 (expiry date: 11/2023).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.

• 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: 17659702
• MDR Text Key: 322375473
• Report Number: 9681442-2023-00311
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001425
• UDI-Public: (01)04049519001425
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX060803C
• Device Lot Number: ANFY2934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• 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