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

Model Number	EX071003CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2023).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.H3 other text : device pending return.
Event or Problem Description
It was reported that during the stent placement procedure in the superficial femoral artery, the stent allegedly appeared wrapped/twisted after finishing deployment.It was further reported that the physician rewired the stent and attempted multiple balloon inflations but was unsuccessful in un-kinking the stent.There was no reported patient injury.
Additional Manufacturer Narrative
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 delivery system was not returned for evaluation.One x-ray image was provided for review.X ray image provided demonstrates the deployed stent inside the vessel appearing like an hour glass which confirms stent twist.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.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: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035¿ diameter guidewire (.)', and 'predilation of the lesion should be performed using standard techniques.' holding and handling of the system during deployment was found sufficiently described, in particular the instruction for use state: ' (.) firmly hold the black system stability sheath throughout deployment.Note: 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.' h10: d4 (expiry date: 03/2023), g3 h11: h6 (method, result, conclusion) 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.
Event or Problem Description
It was reported that during the stent placement procedure in the superficial femoral artery, the stent allegedly appeared wrapped/twisted after finishing deployment.It was further reported that the physician rewired the stent and attempted multiple balloon inflations but was unsuccessful in un-kinking the stent.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR STENT
• Common Device Name: 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: 17151524
• Report Number: 9681442-2023-00235
• Device Sequence Number: 19793007
• Product Code: NIP
• UDI-Device Identifier: 04049519001302
• UDI-Public: (01)04049519001302
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: EX071003CS
• Device Catalogue Number: EX071003CS
• Device Lot Number: ANFZ0453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown