MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Model Number	5F051703CS
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
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: 08/2021), (b)(4).
Event or Problem Description
It was reported that after difficulty advancing the delivery system over the guidewire, through the introducer sheath and through the tracking vessel, the stent successfully deployed in the left proximal superficial femoral artery; however, a segment of the delivery system then allegedly broke and detached within the patient.Reportedly, the delivery system was removed with difficulty and unsuccessful attempts were made to retrieve the segment; therefore, the healthcare provider (hcp) implanted two additional stents of a different manufacturer over the same access site to secure the segment to the vessel wall.There was no reported patient injury.
Event or Problem Description
It was reported that after difficulty advancing the delivery system over the guidewire, through the introducer sheath and through the tracking vessel, the stent successfully deployed in the left proximal superficial femoral artery; however, a segment of the delivery system then allegedly broke and detached within the patient.Reportedly, the delivery system was removed with difficulty and unsuccessful attempts were made to retrieve the segment; therefore, the healthcare provider (hcp) implanted two additional stents of a different manufacturer over the same access site to secure the segment to the vessel wall.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the returned delivery system was investigated, and the tip including distal end of inner catheter was missing.Therefore, a break of the inner catheter was confirmed.During evaluation, a system compatible 0.035" guidewire could be inserted, and the system could be inserted into a system compatible 5f introducer sheath; images demonstrating insertion / removal difficulty were not provided.In this case the tracking vessel was not tortuous and/ or calcified but the user experienced difficulty tracking over the wire and inside vessel/ introducer; the lesion was pre dilated.The deployment was successful, but a long system was used for ipsilateral treatment.A manufacturing related root cause was considered; however, 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 the specification prior to shipment.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant ifu the potential issue was found addressed.The ifu state: 'if resistance is met during stent system introduction, the stent system should be withdrawn 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.' regarding deployment force 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.' the ifu further state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.' regarding ipsilateral procedure the ifu state: 'it is recommended to use the 80 cm working length device for ipsilateral procedures.The longer working length of the 135 cm device may potentially be challenging for the user to keep straight for ipsilateral procedures.Failure to keep the device straight may impede the optimal deployment of the implant.' h10: d4 (expiry date: 08/2021), h6(device code: 1069 - break, 2907 - detachment).H11:section a through f - 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.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9693775
• Report Number: 9681442-2020-00044
• Device Sequence Number: 19268103
• Product Code: NIP
• UDI-Device Identifier: 00801741120671
• UDI-Public: (01)00801741120671
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 5F051703CS
• Device Catalogue Number: 5F051703CS
• Device Lot Number: ANDV1184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR