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

Model Number EX072003CL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Despite good faith efforts to obtain additional information, the complainant was unable to provide further procedural details.

Event Description

It was reported that the vascular stent (7 x 200 mm) was implanted in the left sfa.During post-dilation with a 200 mm balloon, it was noticed that the length of the vascular stent was half of the labeled size.Two additional stents were implanted and the procedure was completed successfully.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.On the basis of the evaluation of the returned device, the alleged stent foreshortening could not be confirmed.The delivery system was found to be in used condition upon sample receipt and the stent was missing as it remains in situ, as reported.No conspicuity was identified indicating that a shorter stent than labeled was loaded in the delivery system.No images showing the stent placed inside the vessel were provided.Therefore, the reported stent foreshortening could not be confirmed.Potential contributing factors to the reported event have been evaluated.Previously reported similar complaints have been reviewed.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre-dilation, highly calcified vessels, the patient's condition or the vessel anatomy may lead to stent foreshortening.In this case, only limited information regarding the procedure performed, the patient's condition, and the accessories used was provided.Reportedly, the stent length was measured in comparison with a 200 mm balloon used for post-dilation which is an inadequate measurement method.On the basis of the information available and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.The ifu supplied with this product as well as the packaging label sufficiently references the dimensions of the stent.Also the ifu states: "pull back the stent system until the distal and proximal stent radiopaque markers are in position so that they are distal and proximal to the target site." in addition, the ifu sufficiently describes the correct stent deployment.Furthermore, the ifu indicates that pre-dilation of the lesion should be performed by using standard techniques.Updated 'eval code & desc - conclusion 1' due to completion of evaluation.

Event Description

It was reported that the vascular stent (7 x 200 mm) was implanted in the left sfa.During post-dilation with a 200 mm balloon, it was noticed that the length of the vascular stent was half of the labeled size.Two additional stents were implanted and the procedure was completed successfully.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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstr. 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6566998
• MDR Text Key: 75149271
• Report Number: 9681442-2017-00178
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402(17)181107(10)ANAY0977
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Model Number: EX072003CL
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANAY0977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 78