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

Model Number	EX070803CS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 or Problem Description
It was reported that after successfully deploying a vascular stent, as the delivery system was being removed a portion of the catheter allegedly detached and remained on the guide wire.Reportedly, the guide wire was removed with the detached portion attached.There was no reported patient injury.
Additional Manufacturer Narrative
A manufacturing review was performed.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.No additional complaint has been reported for this lot number previously.Investigation summary: the alleged failure could not be reproduced because the catheter sample was not returned for evaluation.Images documenting the event have not been provided.Therefore, the investigation will be closed with inconclusive result.A definite root cause for the reported event could not be determined.The reported event represents an off label use of the device.Labeling review: in reviewing the applicable labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'if resistance is met while retracting the stent system over a guidewire, remove the stent system and guidewire together.' regarding preparation the ifu states: 'flush the inner lumen of the stent system with heparinized normal saline prior to use.' regarding the usage of accessories the ifu recommended a 6f (2.0 mm) or larger introducer sheath and a 0.035 inch diameter guidewire of appropriate length.The ifu states:'predilation of the lesion should be performed using standard techniques.' in regards to force increase during deployment 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 product is indicated for use in the native superficial femoral artery (sfa) and popliteal artery.(b)(4).
Event or Problem Description
It was reported that after successfully deploying a vascular stent, as the delivery system was being removed a portion of the catheter allegedly detached and remained on the guide wire.Reportedly, the guide wire was removed with the detached portion attached.There was no reported patient injury.

• Brand Name: LIFESTENT STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7030410
• Report Number: 9681442-2017-00295
• Device Sequence Number: 1523163
• Product Code: NIP
• UDI-Device Identifier: 04049519001265
• UDI-Public: (01)04049519001265
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2018
• Device Model Number: EX070803CS
• Device Catalogue Number: EX070803CS
• Device Lot Number: ANAS2770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 63