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

Catalog Number 5F060201C

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent 5f vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).

Event Description

It was reported that after stent placement, distal part of the stent delivery system allegedly broke into several pieces.It was further that physician allegedly had to perform an open surgery to remove the segment.The current status of the patient was unknown.

Event Description

It was reported that after stent placement, distal part of the stent delivery system allegedly broke into several pieces.It was further that physician allegedly had to perform an open surgery to remove the segment.The current status of the patient was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products are identified in d2 and g4.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 stent delivery system was not returned for evaluation.However, an x-ray image of the placed stent and a photo showing the broken distal end of the inner catheter were provided.Based on the photo the damage of the distal end of the inner catheter is confirmed.The inner catheter was found broken at two sections of the cardan tube.However, a manufacturing related issue could not be determined based on the photo.The x-ray did not contribute to the investigation because of low resolution.Based on information available and the evaluation of the photo provided the reported break of the inner catheter is confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant instruction for use the potential issue was found addressed.The instruction for use state: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." regarding deployment force the instruction 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." in addition, the instruction for use states: "'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 the potential factor of insufficient pre dilation the instruction for use states: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended." under materials required the instruction 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." h10: (expiry date: 01/2024).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.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12777159
• MDR Text Key: 280510745
• Report Number: 9681442-2021-00578
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060201C
• Device Lot Number: ANFN2399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention