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

Model Number EX061703CS

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.

Event Description

It was reported that during the stent placement, the delivery system, the stent, and the guidewire allegedly got stuck on each other causing the stent to come off of the delivery system.There was no reported patient injury.

Event Description

It was reported that during the stent placement, the delivery system, the stent, and the guidewire allegedly got stuck on each other causing the stent to come off of the delivery system.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: a stent delivery system and images were returned for evaluation.Based on the evaluation the reported entrapment could not be reproduced.However, a detachment of the inner catheter from the hypotube could be confirmed.The proximal end of the returned inner catheter was found to be damaged and compressed, which indicated that the inner catheter detached due to increased forces.Residuals of adhesive were found on the proximal part of the inner catheter.Based on evaluation of the sample, no indication for a manufacturing related cause could be found.Labeling review:in reviewing the labeling supplied with this product, it was found that the instructions for use (ifu) sufficiently address the potential risks.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.

Event Description

It was reported that after a successful stent placement, the inner catheter/component got stuck on the guide wire and come off of the delivery system.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: a stent delivery system and images were returned for evaluation.Based on the evaluation the reported entrapment could not be reproduced.However, a detachment of the inner catheter from the hypotube could be confirmed.The proximal end of the returned inner catheter was found to be damaged and compressed, which indicated that the inner catheter detached due to increased forces.Residuals of adhesive were found on the proximal part of the inner catheter.Based on evaluation of the sample, no indication for a manufacturing related cause could be found.Furthermore, three images were provided.One of them shows the labeling part and the other two show the device in the same condition as returned.As a result of the investigation performed the complaint is confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: 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: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." regarding preparation of the devices the ifu states: "flush the inner lumen of the device with saline prior to use".Regarding use of accessories the ifu states: ".The following standard materials may also be required to facilitate delivery and deployment of the lifestent® xl vascular stent system:., 6f (2.0 mm) or larger introducer sheath, 0.035¿ diameter guidewire,." h11: b5, d2, g1, h6 (result 1 - code 114 removed) device code 1212 (entrapment) removed.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8545357
• MDR Text Key: 142940839
• Report Number: 9681442-2019-00061
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

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: 07/20/2020
• Device Model Number: EX061703CS
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANCU2592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 10/02/2019
• Supplement Dates FDA Received: 06/26/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 68