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

Model Number	EX062003CL
Medical Device Problem Codes	Break (1069); Fracture (1260); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to bd for evaluation.A stent delivery system was returned for evaluation.Based on the evaluation of the returned sample a stent fracture could be confirmed.The stent was found to be partially deployed and the stent was found fractured.An indication for a manufacturing related issue could not be found.Potential factors that could have led or contributed to the reported event have been considered.A manufacturing related root cause was considered, however, the lot history records have been 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.Based on the information available, and the evaluation of the returned catheter sample, a definite root cause could not be identified.(b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model ex062003cl vascular stent allegedly experienced a break, misfire, fracture, and premature deployment.This information was received from a single source.The alleged break, misfire, fracture, and premature deployment involved a patient with no known impact to the patient.

• Brand Name: LIFESTENT SOLO 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: 8794091
• Report Number: 9681442-2019-00099
• Device Sequence Number: 1977641
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• 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
• Report Date (Section B): 07/16/2019

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: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCV1916
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1