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

Catalog Number	EX072003CL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during a stent placement procedure in the pre-dilated sfa via cfa access, the vascular stent could not be deployed any further after being partially released 1 mm.Another stent was used to complete the procedure successfully.There was no reported patient injury.
Additional Manufacturer Narrative
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 all specifications prior to shipment.The evaluation of the returned catheter sample confirmed that the stent was partially released when the deployment system broke and that the system including partially released stent could be successfully removed.A force transmitting component was found broken at the proximal end so that a successful stent deployment was not possible.The grip mechanics were found in good condition so that it was concluded that increased friction in the catheter section was present during attempted deployment which led to increased release force and subsequent deployment failure.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The event reported may be related to a difficult anatomy as highly tortuous and calcified vessels may lead to increased friction and subsequent release force increase.Reportedly, no difficulty was encountered advancing and retracting the system to and from the lesion site.The lesion was pre-dilated.Furthermore, the event reported may be use-related as rough handling may lead to friction increase.Based on the information available and the evaluation of the sample returned, a definite root cause for the event reported could not be determined.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 "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'.Furthermore, a 0.035 inch guidewire and a 6f or larger introducer sheath is required based on the ifu.
Event or Problem Description
It was reported that during a stent placement procedure in the pre-dilated sfa via cfa access, the vascular stent could not be deployed any further after being partially released 1 mm.Another stent was used to complete the procedure successfully.There was no reported patient injury.

• 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: 5782234
• Report Number: 9681442-2016-00193
• Device Sequence Number: 260222
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402(17)160725(10)ANYG3488
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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 Expiration Date: 07/25/2016
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANYG3488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 08/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 61