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

Catalog Number EX071003CS

Device Problems Break (1069); Positioning Failure (1158); Retraction Problem (1536); Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2015

Event Type  Injury  

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 / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the vascular stent did not deploy correctly in the left iliac.Another stent was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Based on the lot history review the used 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.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample and no images were provided for evaluation.Therefore, the reported problem could not be reproduced and the investigation will be closed with inconclusive result.Potential factors that could have led or contributed to the reported issue have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.Difficult patient anatomy or a challenging placement site may result into high friction during the attempt to release the stent and may be also contributing factors for retraction issues of a partially released stent.In this case it was reported that the tracking vessel was heavily calcified and tortuous.Based on the information available and as no sample was 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: "if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit." the reported application represents an off-label use of the device.The lifestent xl vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and proximal popliteal artery with reference vessel diameters ranging from 4.0-6.5 mm.The lifestent xl biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.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 vascular stent did not deploy correctly in the left iliac.During retraction of the delivery system through the vessel bifurcation the partially released stent deployed in the right iliac artery.There was no reported attempt to retrieve the deployed stent in the right iliac artery.A second access was gained to deploy a second stent in the left iliac artery.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 evaluation of the returned device confirmed the breakage of a force transmitting component.Increased friction is considered the reason for increased release force and subsequent breakage of the force transmitting component.The stent was not part of the sample return; reportedly it had been implanted.Due to the sample condition, the point in time of the breakage of the component could not be determined.Therefore, a partial stent deployment could not be reproduced.As no images were provided, the reported malposition of the stent could not be verified.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.A difficult vessel anatomy or challenging placement site may result in high friction during the attempt to release the stent.In this case, the tracking vessel was heavily calcified and tortuous.A difficult vessel anatomy or challenging placement site may also contribute to retraction issues of a partially released stent.Reportedly, the device was used to treat the left iliac artery via access over the right common femoral artery.Based on the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.The ifu states: "if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit." the reported application represents an off-label use of the device.The ifu states that the lifestent xl vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery and proximal popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.The lifestent xl biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

• Brand Name: LIFESTENT 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: 4987716
• MDR Text Key: 23935238
• Report Number: 9681442-2015-00115
• Device Sequence Number: 1
• Product Code: NIP
• 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: Physician
• Type of Report: Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2016
• Device Catalogue Number: EX071003CS
• Device Lot Number: ANYG3482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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: 45 YR
• Patient Weight: 75