MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Model Number	5F051003CS
Medical Device Problem Codes	Fracture (1260); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The investigation of the reported event is currently underway.(expiry date: 04/2024).
Event or Problem Description
It was reported that during a stent placement superficial artery (sfa) procedure through the left common femoral access, the stent started to allegedly prematurely deploy while advancing up and over the bifurcation.The procedure was completed by using another device.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.Investigation summary: the sample was returned for evaluation.The returned sample was found with locked safety mechanism and with partially released stent which confirms premature deployment.The distal stent end was found fractured off which was considered a subsequent event.An indication for a process related issue could not be found.The investigation leads to confirmed result for premature deployment.The vessel was not tortuous/ calcified, the lesion was pre dilated, and resistance was not felt; system compatible introducer and guidewire were used, and the guidewire was running smoothly inside the system.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.Caution: always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.' the instructions for use further state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.Visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.' in regards to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' in regards to materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath (.) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.H10: d4 (expiry date: 07/2024), g3, h6 (device) h11: d4(medical device catalog number, medical device lot number), 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 a stent placement superficial artery (sfa) procedure through the left common femoral access, the stent started to allegedly prematurely deploy while advancing up and over the bifurcation.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: LIFESTENT 5F 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13533169
• Report Number: 9681442-2022-00032
• Device Sequence Number: 17430144
• Product Code: NIP
• UDI-Device Identifier: 00801741120633
• UDI-Public: (01)00801741120633
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/15/2022

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: 5F051003CS
• Device Catalogue Number: 5F050803CS
• Device Lot Number: ANFU3936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/26/2022
• 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