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

Catalog Number	EX062001CL
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
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 stenting procedure of the mid sfa via antegrade approach, the outer catheter of the delivery system broke and the vascular stent could not be deployed.Another stent of the same brand was used to complete the procedure successfuly.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.There is no indication for a manufacturing-related failure.During the evaluation of the returned device, the stent was found to be partially released and could not be deployed any further during the performed function test.The condition of the device indicates the presence of increased friction finally leading to the reported failure to deploy the stent.According to the event description, the outer catheter broke during the attempt to deploy the stent.However, as no broken component was identified during sample evaluation, the reported breakage could not be confirmed.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to a difficult anatomy as highly tortuous or calcified vessels can lead to increased friction and subsequent release force increase.Reportedly, the lesion had been pre-dilated.The event also may be use-related as rough handling of the device can lead to deformation and subsequent friction increase.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "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." updated data; sample was received.Updated 'eval code & desc - conclusion 1'; evaluation completed.
Event or Problem Description
It was reported that during a stenting procedure of the mid sfa via antegrade approach, the outer catheter of the delivery system broke and the vascular stent could not be deployed.Another stent of the same brand 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: 5885162
• Report Number: 9681442-2016-00230
• Device Sequence Number: 16363604
• Product Code: NIP
• UDI-Device Identifier: 04049519004105
• UDI-Public: (01)04049519004105(17)160808(10)ANYH1053
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/03/2016

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: 08/08/2016
• Device Catalogue Number: EX062001CL
• Device Lot Number: ANYH1053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 57