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

Catalog Number EX060803C

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, image, photo and videos were provided for review.The investigation of the reported event is currently underway.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 and 510 k number for the lifestent vascular stent system products are identified.Medical device expiry date: 04/2023.Device pending return.

Event Description

It was reported that during a stent placement at the proximal end of the right superficial femoral artery, the stent allegedly failed to deploy.It was further reported that the stent got stuck in the sheath and allegedly detached.Reportedly, the stent was allegedly broken and retained in the patient body which was removed via a surgical operation.Patient reported as stable.

Manufacturer Narrative

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 510 k number for the lifestent vascular stent system 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, photos and video files were provided for evaluation, which demonstrate the fractured-off stent end close to the introducer sheath, break of the guidewire lumen, and deployment of the stent inside the introducer.It was not known what caused the alleged deployment failure, and how the stent was deployed inside the introducer.The investigation leads to confirmed result for catheter break and stent fracture inside patient.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.', and 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035-inch (0.89 mm) diameter guidewire of appropriate length'.In regard to pta the instructions for use state: 'predilitation of the lesion should be performed using standard techniques.' holding and handling of the system throughout deployment was found addressed, in particular the instructions for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' in regard to removal difficulty the instructions for use state: 'if resistance is met while retracting the stent system over a guidewire, remove the stent system and guidewire together.' h10: d4 (expiry date: 04/2023), g3 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 during a stent placement at the proximal end of the right superficial femoral artery, the stent allegedly failed to deploy.It was further reported that the stent got stuck in the sheath and allegedly detached.Reportedly, the stent was allegedly broken and retained in the patient body which was removed via a surgical operation.Patient reported as stable.

• Brand Name: LIFESTENT 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: 13547635
• MDR Text Key: 285729119
• Report Number: 9681442-2022-00039
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001425
• UDI-Public: (01)04049519001425
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX060803C
• Device Lot Number: ANFR1434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 04/27/2022
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 58 KG