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

Catalog Number	EX061503CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
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 returned catheter sample was found in used but fully functional condition not indicating stent twisting.Provided image demonstrates two overlapping stents and an hourglass like deformation of one stent close to the overlapping zone which confirms stent twisting.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 instructions for use closely describes holding and handling of the system throughout deployment.In particular the instructions 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'.The instructions for use further state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035¿diameter guidewire'.Regarding pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques' and 'post stent expansion with a pta catheter is recommended'.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 or Problem Description
It was reported that during a stent placement procedure in the superficial femoral artery stenosis, the stent allegedly twisted.It was further reported that the pta balloon was used to untwist the balloon.However, once the balloon was deflated, the stent allegedly got twisted again.Reportedly, the twisted stent was removed and the procedure was not continued.There was no reported patient injury.
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, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2026).H11: d2b (nip; fge).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 or Problem Description
It was reported that during a stent placement procedure, the stent allegedly twisted.It was further reported that the pta balloon was used to untwist the balloon.However, once the balloon was deflated the stent allegedly got twisted again.Reportedly, the twisted stent was removed and the procedure was not continued.There was no reported patient injury.

• Brand Name: LIFESTENT XL 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: 20215274
• Report Number: 9681442-2024-00301
• Device Sequence Number: 7745690
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296(17)260105(10)ANJN0858
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANJN0858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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