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

Catalog Number UNK LIFESTENT 5F

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, image were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that during a stent placement procedure, the foreign matter was found in the device.It was further reported that the foreign material removed.The patient status was unknown.

Manufacturer Narrative

H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: a device sample or the segment retrieved from the patient were not returned for evaluation.However, an x-ray and photos of the segment were provided for evaluation.An x-ray was provided showing the forearm of a patient, with two stents placed in an arteriovenous fistula.The stents were placed overlapping; a longer stent of a competitor and a shorted lifestent 5f stent.One end of the competitor stent was placed in a curve, while the lifestent 5f was placed in a straight section right after the curve.A segment of a catheter was found inside the lifestent 5f, with an estimated length of 50mm.Two photos were also provided.The first image is showing the distal end of a lifestent 5f delivery system inside a blue kidney basin.The second photo is a close up of the same segment showing the cardan tube of the inner catheter including the atraumatic tip of a lifestent 5f inner catheter.Based on information available and the evaluation of the images provided a break of the inner catheter during the initial stent deployment procedure is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the instructions for use supplied with this product the potential issue was found addressed.The instructions for use states: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." regarding deployment force the instructions for use 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." regarding the potential factor of insufficient pre dilation the instructions for use states: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath (¿) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire." placement of the stent in an av fistula represent an off label use of the device.Based on the instructions for use supplied with this product, the lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (sfa) and popliteal artery.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.H3 other text : device not returned.

Event Description

It was reported that during a fistulagram, a foreign part was found between two stents that have been previously placed.There was an attempt to retrieve the foreign part with a snare without success.The part was removed during an open procedure.After the foreign part was removed the procedure was completed with a fistuloplasty as initially planned.The current patient status is unknown.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11647388
• MDR Text Key: 253201842
• Report Number: 9681442-2021-00221
• Device Sequence Number: 1
• Product Code: NIP
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LIFESTENT 5F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention