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

Model Number	5F051703CS
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Misfire (2532); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.(b)(4).
Event or Problem Description
Xncnthis report summarizes one malfunction.A review of the reported information indicated that model 5f051703cs vascular stent system allegedly experienced failure to deploy, misfire, device-device incompatibility, and difficulty advancing.This information was received from one source.The malfunction involved one patient with no patient consequence.The one patient was reported as a (b)(6) year old male of unknown weight.
Additional Manufacturer Narrative
H10: the device for this malfunction has been returned to the manufacturer for evaluation.The investigation confirmed for the reported deployment failure.Based on the information available and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.The device is labeled for single use.H10: g4, h6 (device codes: material deformation - 2976).H11: h6 (device), h6 (results, 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
This report summarizes one malfunction.A review of the reported information indicated that model 5f051703cs vascular stent system allegedly experienced failure to deploy, misfire, device-device incompatibility, and difficulty advancing.This information was received from one source.The malfunction involved one patient with no patient consequence.The one patient was reported as a 58 year old male of unknown weight.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9187064
• Report Number: 9681442-2019-00161
• Device Sequence Number: 16756277
• Product Code: NIP
• UDI-Device Identifier: 00801741120671
• UDI-Public: (01)00801741120671
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: No Information
• Device Model Number: 5F051703CS
• Device Catalogue Number: 5F051703CS
• Device Lot Number: ANCZ2853
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1