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

Catalog Number EX062003CL

Device Problems Positioning Failure (1158); Kinked (1339); Dent in Material (2526); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided by bard 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 bard.

Event Description

It was reported that the vascular stent would not deploy in the sfa.A kink was noticed on the delivery system shaft.There was no reported patient injury.

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.The evaluation of the returned device confirmed the reported failure to deploy the stent caused by the breakage of a force transmitting component of the delivery system.The condition of the system indicates the presence of high release force.Increased friction is considered the reason for the increased release force and subsequent deployment failure.A section with bends and dents in the delivery system catheter was detected.Potential contributing factors 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 may lead to increased friction and subsequent release force increase.The event also may be use-related as rough handling of the device can lead to deformation and subsequent friction increase.The use of inappropriate accessories or a not performed balloon pre-dilation also may be contributing factors.In this case, no procedural or other additional information was provided.The bends and dents in the delivery system sheath could have contributed to an increased release force; however, it could not be determined when and why this deformation occurred.Based on 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." and "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." the ifu also recommends balloon pre-dilation and the use of a 0.035" guide wire.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 4987748
• MDR Text Key: 23859917
• Report Number: 9681442-2015-00117
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2016
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANYL0772
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1