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

Model Number	EX062003CL
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that upon removal from the packaging, a bend was allegedly identified toward the back of the delivery catheter, but the healthcare professional decided that the delivery system was still operable.It was further reported that upon advancement to treat the right superficial femoral artery, the delivery catheter allegedly broke.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that upon removal from the packaging, a bend was allegedly identified toward the back of the delivery catheter, but the healthcare professional decided that the delivery system was still operable.It was further reported that upon advancement to treat the right superficial femoral artery, the delivery catheter allegedly broke.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: based on the lot history review the used product complied with all manufacturing specifications leading to final device release.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.Investigation summary: a stent delivery system was returned.Based on the evaluation of the returned sample the reported issue could be confirmed.The system was returned in unused condition with locked safety slider and the sheath was found to be kinked in several sections.In one kink a complete break of the system was identified.An indication for a process related issue could not be found.Based on the information available, and the evaluation of the returned sample a definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding unpacking the ifu states: 'do not rotate the grip while extracting the stent system from the tray.' furthermore the ifu states: '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 must not be used.' and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.'.

• 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: 8297825
• Report Number: 9681442-2019-00012
• Device Sequence Number: 11378386
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: Health Professional
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCT3552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR