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

Catalog Number EX072003CL

Device Problems Positioning Failure (1158); Kinked (1339)

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

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

As the lot number of the subject device has not been provided, a device history record review could not be performed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide further product, patient or procedural details to date.

Event Description

It was reported that during a stenting procedure of the distal sfa / proximal popliteal artery, the vascular stent could not be deployed.Reportedly, the delivery system could be advanced without difficulties to the lesion which had not been pre-dilated, and neither the tracking path nor the target lesion were tortuous or calcified.The delivery system was removed without issue and two other vascular stents of the same brand (size 7 x 150 and 7 x 60) were used to complete the procedure successfully.No patient injury was reported.

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 examination of the returned device confirmed the reported failure to deploy the stent.The deployment mechanism was found to have been used and a force transmitting component was found to be broken preventing a successful stent deployment.Increased friction may have led to excessive release force and subsequent deployment failure.Also a kink was found in the distal catheter section which may have led to increased release force but it is unknown at which point in time this kink occurred.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The 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 reported event also may be use-related as rough handling of the device can lead to deformation and subsequent friction increase.Reportedly, the lesion had not been pre-dilated which is considered another contributing factor to the reported event.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." 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 also states: "pre-dilation of the lesion should be performed using standard techniques.".

• 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5611737
• MDR Text Key: 43789824
• Report Number: 9681442-2016-00120
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 05/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2014
• 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
• Patient Age: 94 YR
• Patient Weight: 72