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

Model Number	5F060603CS
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly failed to deploy.Upon removing the stent system, the tip allegedly broke off in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not returned for evaluation and images were not provided for review.Based on the information available, the investigation is inconclusive for deployment failure and tip break.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 state: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in regards to pre dilation the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under 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'.Holding and handling of the system during deployment was found sufficiently described.In regards to removal difficult over the wire the instructions for use state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together' 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 procedure, the stent allegedly failed to deploy.Upon removing the stent system, the tip allegedly broke off in the patient.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: 12468030
• Report Number: 9681442-2021-00508
• Device Sequence Number: 4346500
• Product Code: NIP
• UDI-Device Identifier: 00801741120169
• UDI-Public: (01)00801741120169
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 02/18/2022

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: 5F060603CS
• Device Catalogue Number: 5F060603CS
• Device Lot Number: UNKNOWN
• 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: 08/18/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 02/22/2022
• 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
• Patient Sex: Unknown