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

Catalog Number EX062003CL

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 any patient or procedural details to date.

Event Description

It was reported that the vascular stent could not be deployed any further after being partially released and appeared to be twisted.The stent delivery system and introducer sheath were removed as a single unit without issue.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 any further after being partially released due to the breakage of a force transmitting component.On the basis of the condition of the returned device, increased friction is considered the reason for increased release force and subsequent breakage of the force transmitting component.Potential factors that could have led or contributed to reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to difficult anatomical conditions as tortuous or calcified vessels may lead to increased friction.Also a not performed pre-dilation of the lesion may be a contributing factor to the reported event.In this case, no procedural or anatomical details were provided.The reported event also may be use-related as rough handling of the device can lead to friction increase.On the basis of the information available, 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, the ifu recommends pre-dilation.

• 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: 5230599
• MDR Text Key: 31585422
• Report Number: 9681442-2015-00218
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S047
• 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: 10/23/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANYJ3367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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