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

Catalog Number EX062003L

Device Problems Positioning Failure (1158); Physical Resistance (2578)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that during a stenting procedure, resistance was noted and the vascular stent could not be deployed.The delivery system with the vascular stent was removed without issue.

Manufacturer Narrative

Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under (b)(4).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 or unwilling to provide any patient or procedural details to date.

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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample or image was provided.Therefore, the reported event could not be reproduced.Potential factors that could have contributed to the reported deployment failure have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to a difficult anatomy as highly tortuous or calcified vessels may lead to increased friction and subsequent release force increase.In this case, no procedural or anatomical details were provided.The event also may be related to rough handling of the device during preparation or use.Based on the information available and as no sample was returned, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct deployment of the stent.Also the ifu states: "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.".

Manufacturer Narrative

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.

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 delivery system confirmed the reported event.The stent was found to be partially released upon sample receipt.High friction forces were present during the attempt to deploy the stent resulting in the reported deployment failure.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to a difficult anatomy as highly tortuous or calcified vessels may lead to increased friction and subsequent release force increase.In this case, no procedural or anatomical details were provided.The event also may be related to rough handling of the device during preparation or use.Based on the information available and the sample evaluation, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct deployment of the stent.Also the ifu states: "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.".

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe ; GM
• 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: 4897832
• MDR Text Key: 6830150
• Report Number: 9681442-2015-00093
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: EX062003L
• Device Lot Number: ANZA3352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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