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

Catalog Number EX051203C

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 06/21/2020

Event Type  Injury  

Manufacturer Narrative

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; however, photo and image were provided.The investigation of the reported event is currently underway.Expiry date (08/2021).The catalog number identified has not been cleared in the us, but is similar to the lifestent vascular stent system products that are cleared in the us.The pro code for the lifestent vascular stent system products is identified.

Event Description

It was reported that after approximately two months post stent placement to treatment a total occlusion in the right sfa in an off-label subintimal technique, the stent was identified allegedly fractured in three locations under imaging within the subintimal space.It was further reported that medical intervention was performed by performing two additional angioplasty procedures in the highly calcified lesion, and the health care provider is considering using another manufacturer¿s stent to place inside the fractured stent in a future procedure.Patient is currently stable.

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 device was not available for evaluation, the stent remains implanted.One x-ray image was provided demonstrating three separated fragments of the stent in the sfa.The visibility was poor so that the strut structure could not be evaluated, but the complete fracture of the stent could be confirmed.In this case the lesion was pre dilated, the vessel was not tortuous but highly calcified, and the stent could be deployed without difficulty; stent elongation was reportedly not observed.Based on the information available a definite root cause for the reported event could not be identified.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use sufficiently address this potential risk.The instructions for use describe the stent deployment procedure by stating: 'confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.(.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.(.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum.(.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' balloon pre and post dilation was addressed: 'predilatation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' the instructions for use further state: 'cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture.' h10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent vascular stent system products that are cleared in the us.The pro code and 510k number for the lifestent vascular stent system products is identified in d2 and g5.H10: d4(expiry date: 08/2021), g4 h11: h6 (results, conclusion) 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.

Event Description

It was reported that after approximately two months post stent placement to treatment a total occlusion in the right sfa in an off-label subintimal technique, the stent was identified allegedly fractured in three locations under imaging within the subintimal space.It was further reported that medical intervention was performed by performing two additional angioplasty procedures in the highly calcified lesion, and the health care provider is considering using another manufacturer¿s stent to place inside the fractured stent in a future procedure.Patient is currently stable.

• 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
• MDR Report Key: 10287764
• MDR Text Key: 199260915
• Report Number: 9681442-2020-00180
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007762
• UDI-Public: (01)04049519007762(17)211108
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX051203C
• Device Lot Number: ANDY0876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR