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

Catalog Number EX062003CL

Device Problems Positioning Failure (1158); Kinked (1339); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot history records have been reviewed and the product complied with all manufacturing specifications leading to final device release.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.Based on the investigation of the returned catheter sample it is confirmed that the stent could not be deployed.A force transmitting component was found broken so that the deployment action did not lead to a successful stent deployment.The distal section of the delivery system was found with a necking pattern which indicated that excessive release force was present before the force transmitting component broke.It was therefore concluded that increased friction in the distal catheter section led to excessive release force and subsequent deployment failure.Furthermore, the system was found kinked which was considered a consequence of the deployment failure.A lock mechanism failure is unconfirmed because during evaluation the grip was opened and the lock/ unlock mechanism was found in good condition.Potential factors that could have led or contributed to increased release force and subsequent deployment failure have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.The event reported may be related to a difficult anatomy as highly tortuous and calcified vessels may lead to increased friction and subsequent release force increase.The event reported may also be use related as rough handling may lead to deformation and subsequent friction increase.Not performed balloon pre dilation may be a contributing factor; however, it was not known whether the lesion was pre dilated.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.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 states that balloon pre dilation should be performed using standard technique.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 device was unable to be used and another device was used to complete the procedure.There was no reported patient injury.

• 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: 5458416
• MDR Text Key: 38972233
• Report Number: 9681442-2016-00055
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303(17)170116(10)ANZA1515
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2017
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANZA1515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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