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

Catalog Number 5F050803C

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

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 records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2025).

Event Description

It was reported that during a stent placement procedure, the catheter shaft allegedly broke off inside patient.Piece was retrieved with a snare from iliac artery.There was no reported patient injury.

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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the sample was returned for evaluation.The returned sample was found in used condition without stent, which reportedly had been deployed inside patient.The inner catheter cardan tube was found broken twice at the proximal end and at the distal end, and the detached distal end was part of the sample return so that no part of missing.The investigation leads to confirmed result for inner catheter cardan tube break and detachment.An indication for a process related issue could not be found.The vessel was not tortuous but calcified, 6f introducer with 0.014¿ guidewire were used for access, and the lesion was pre dilated.The system was correctly held at the introducer sheath, the user did not experience difficulty/ force increase, and the guidewire was running smoothly inside the system.Based on the information available the investigation is closed with confirmed result for inner catheter 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 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 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 states: '5f (1.67 mm) or larger introducer sheath (¿); 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter guidewire'.Regarding insertion and removal difficulty of the delivery system the instructions for use states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.H10: (expiry date: 06/2025).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, the catheter shaft allegedly broke off inside patient.Piece was retrieved with a snare from iliac artery.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15866771
• MDR Text Key: 307784148
• Report Number: 9681442-2022-00341
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F050803C
• Device Lot Number: ANGT1105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/26/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/20/2022
• 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