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

Model Number	EX061503CS
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 03/2021).
Event or Problem Description
It was reported that post successful stent deployment in the right superficial femoral artery via access through the left femoral artery, as the delivery system was removed over the guidewire, the delivery system allegedly detached from itself once out of the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided, and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the inner assembly detached from the outer sheath.The inner assembly was found detached from the grip at an adhesive joint at the proximal end of the grip.Adhesive was found applied so that missing adhesive could be excluded as reason for the detachment.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The ifu state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.' in regards to accessories the ifu state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035¿ diameter guidewire of appropriate length.', and 'predilation of the lesion should be performed using standard techniques.' in regards to tracking resistance the ifu state: 'if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.' and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' 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.
Event or Problem Description
It was reported that post successful stent deployment in the right superficial femoral artery via access through the left femoral artery, as the delivery system was removed over the guidewire, the delivery system allegedly detached from itself once out of the patient.There was no reported patient injury.

• Brand Name: LIFESTENT STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9340464
• Report Number: 9681442-2019-00218
• Device Sequence Number: 14133653
• Product Code: FGE
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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 Model Number: EX061503CS
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANDQ1417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1