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

Catalog Number EX062003CL

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 01/31/2014

Event Type  Injury  

Event Description

It was reported that during a vascular stenting procedure in the sfa, the vascular stent was partially deployed when the deployment system became blocked.An unsuccessful attempt was made to complete the stent deployment manually.Upon the attempt to remove the delivery system and the stent with a snare device, the inner and outer catheter broke off near the partially deployed vascular stent.An intervention was performed to remove the partially deployed stent and remaining section of the delivery system sheath successfully.Two additional covered vascular stents were deployed in the sfa to treat the patient.

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.No other complaint has been received for this lot number.The evaluation of the returned sample confirmed that the stent was partially released.The returned delivery system was found to be broken in small pieces and kinked in several positions.Due to the poor sample condition, the reported event could not be reproduced in detail.As it was reported that the trigger mechanism became difficult to engage, increased friction and increased release force is considered the reason for the failure to completely deploy the stent.No further information could be gained out of the images received.There is no indication for a manufacturing-related failure.Potential factors that could have led or contributed to the increased friction and subsequent deployment failure have been evaluated.Previous investigations of similar complaints have been reviewed.The event may be related to difficult anatomical conditions as tortuous or calcified vessels may lead to increased friction.Also, the event may be use-related as rough handling of the device may lead to deformation and subsequent release force increase.On the basis of the information available and condition of the sample, a definite root cause for the event reported could not be determined.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 3676845
• MDR Text Key: 4261867
• Report Number: 9681442-2014-00039
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANXH2023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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
• Patient Outcome(s): Required Intervention