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

Model Number	5F051003CS
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, the return of the device is pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 5f051003cs vascular stent allegedly experienced detachment.This information was received from one source.One patient was involved with no reported patient injury.The female patient is (b)(6) and weighs (b)(6).
Additional Manufacturer Narrative
H10: the lot number was provided for this malfunction; therefore, a lot history review was performed.The device was returned for evaluation.Based on the evaluation of sample, the inner catheter was found broken and the distal end including the tip was found to be missing.Furthermore, kink was identified on the entire length of the stent sheath.Based on the available information, a definitive root cause could not be determined.The device is labeled for single use.H10: g4, h6 (device: 2976 - material deformation).H11: 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
This report summarizes one malfunction.A review of the reported information indicates that model 5f051003cs vascular stent allegedly experienced detachment.This information was received from one source.One patient was involved with no reported patient injury.The female patient is 64 years old and weighs 55 kgs.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10261400
• Report Number: 9681442-2020-00141
• Device Sequence Number: 2496572
• Product Code: NIP
• UDI-Device Identifier: 00801741120640
• UDI-Public: (01)00801741120640
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• 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): 10/08/2020

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: 5F051003CS
• Device Catalogue Number: 5F051003CS
• Device Lot Number: ANDR2884
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1