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

Model Number	EX061703CS
Medical Device Problem Codes	Fracture (1260); Obstruction of Flow (2423); Misfire (2532); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 11/2022).
Event or Problem Description
It was reported that during a stent placement procedure in the distal superficial femoral artery, the device allegedly occluded.It was further reported that the central part of the device did not fully deploy and became crimped upon removal.Reportedly, the patient vessel occluded and was treated with thrombolytics.The patient also underwent serial dilation and re-stenting.The current patient status is unknown.
Event or Problem Description
It was reported that during a stent placement procedure in the distal superficial femoral artery, the device allegedly occluded.It was further reported that the central part of the device did not fully deploy and became crimped upon removal.Reportedly, the patient vessel occluded and was treated with thrombolytics.The patient also underwent serial dilation and re-stenting.The current patient status is unknown.
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.Investigation summary: the sample was not returned for evaluation and image was not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product potential issues were found addressed.The instructions for use describes holding and handling of the system throughout deployment; in particular the instructions for use states: "do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment." and "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 the instructions for use states: "always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.A 6f (2.0 mm) or larger introducer sheath is recommended." and "insert a 0.035¿ diameter guidewire of appropriate length (see table) across the lesion to be stented via the introducer sheath", and "predilation of the lesion should be performed using standard techniques." a stent selection table is part of the instructions for use describing the relationship between reference vessel diameter and the unconstrained stent inner diameter.The instructions for use further states: "the lifestent xl vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and popliteal artery(.)", "the safety and effectiveness of stent overlapping in the middle (p2) and distal popliteal artery (p3) has not been established.", and "the safety and effectiveness of this device for use in treatment of instent restenosis has not been established." h10: d4 (expiry date: 11/2022), g3, h6(device).H11: g1, h6 (method).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.

• 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: 13788572
• Report Number: 9681442-2022-00077
• Device Sequence Number: 16566303
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EX061703CS
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANEY0587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 05/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown