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

Model Number EX051503CS

Device Problems Break (1069); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

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 was unable to provide any further patient details to bard.

Event Description

It was reported that the stent delivery system could not be retracted through a 6 f introducer sheath.Reportedly, the delivery system broke inside the sheath, however, the broken part was removed successfully.The procedure was completed with no issues and the vascular stent was post-dilated.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 stent delivery system was not provided for evaluation; only the torn-off segment of the inner catheter of 219 mm length was returned.On the basis of the information available, the breakage of the inner catheter occurred during retraction of the delivery system through the introducer sheath.Neither the delivery system nor the introducer sheath used during the procedure were returned for evaluation; therefore, the reported difficulties in removing the delivery system through the introducer sheath could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to increased friction between the components of the stent delivery system and the accessories used (e.G., guide wire, introducer sheath).Also the usage of inappropriate accessories or a difficult vessel anatomy as well as insufficient flushing of the device prior to use may be contributing factors to increased friction and subsequent breakage of the inner catheter.In this case, a 6 f introducer sheath was used, however, no information was provided regarding the size of the guide wire used.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.The ifu states that the inner lumen of the device must be flushed with heparinized normal saline prior to use.Furthermore, the ifu states: "if resistance is met while retracting the stent system over a guide wire, remove the stent system and guide wire together." in addition, the ifu indicates that a 6 f (2.0 mm) or larger introducer sheath and a 0.035" guide wire of appropriate length are required for the procedure.Also the ifu states: "examine the stent system for any damage.If it is suspected that the sterility or performance of the device has been compromised, the stent system should not be used.".

Event Description

It was reported that the stent delivery system could not be retracted through a 6 f introducer sheath.Reportedly, the delivery system broke inside the sheath, however, the broken part was removed successfully.The procedure was completed with no issues and the vascular stent was post-dilated.There was no reported patient injury.

• Brand Name: LIFESTENT XL 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: 6489296
• MDR Text Key: 72662427
• Report Number: 9681442-2017-00140
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007946
• UDI-Public: (01)04049519007946(17)180909(10)ANAW1353
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: EX051503CS
• Device Catalogue Number: EX051503CS
• Device Lot Number: ANAW1353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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