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

Catalog Number 5F051203CS

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Misfire (2532); Device Dislodged or Dislocated (2923)

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

Event Date 07/14/2021

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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2023).

Event Description

It was reported that during a stent placement procedure, the tip of the stent allegedly broken and partially deployed.It was further reported that additional access site used to remove the segments.Patient reported as stable.

Event Description

It was reported that during a stent placement procedure in the distal sfa with bilateral access (ipsilateral dorsalis pedis and contralateral femoral), the stent was difficult to deploy than usual with turning the wheel for deployment after 1-2 cm of stent deployment, and upon removal, the catheter tip was found to be completely fractured from the rest of the delivery catheter.Reportedly, upon retrieving the stent catheter from the vessel, the distal end of the stent allegedly dislodged in the right lower extremity vessel.It was further reported that fractured catheter were attempted to be removed with a snare from both access sites was not successful and the piece of catheter fragmented into 3 pieces.Patient reported as stable.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 procedure in the distal sfa with bilateral access (ipsilateral dorsalis pedis and contralateral femoral), the stent was difficult to deploy than usual with turning the wheel for deployment after 1-2 cm of stent deployment, and upon removal, the catheter tip was found to be completely fractured from the rest of the delivery catheter.Reportedly, upon retrieving the stent catheter from the vessel, the distal end of the stent allegedly dislodged in the right lower extremity vessel.It was further reported that fractured catheter were attempted to be removed with a snare from both access sites was not successful and the piece of catheter fragmented into 3 pieces.Patient reported as stable.

Manufacturer Narrative

H10: manufacturing review: two lot numbers were provided, but it was not known which lot number caused the complaint.However, a manufacturing related root cause was considered; therefore, the lot history records 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 sample was returned to the manufacturer for evaluation.The investigation of the returned catheter sample confirmed that the system was in use and that the stent had been deployed.The inner assembly cardan tube was broken at the distal end, and the distal end including tip was missing.Images/ dicoms demonstrating deployment difficulty or the pieces inside patient, or the removal attempt were not provided.In this case the lesion was pre dilated, and system compatible introducer and guidewire were used.The investigation is confirmed for inner assembly cardan tube break.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: '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 regards to pre dilation the instruction for use state: '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'.In regards to removal difficulty the instruction for use state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' h11: section a through f ¿ the information provide by bd represents all 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
• 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: 12317202
• MDR Text Key: 266369008
• Report Number: 9681442-2021-00439
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/03/2022

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: 5F051203CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 02/03/2022
• Supplement Dates FDA Received: 01/13/2022; 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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