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

Catalog Number EX061503C

Device Problems Loss of or Failure to Bond (1068); Break (1069); Difficult or Delayed Positioning (1157); Fracture (1260); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Stenosis (2263)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent 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 return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2022).Device pending return.

Event Description

It was reported that during a stent placement procedure, the stent allegedly was difficult to advance.It was further reported that stent had difficulty in deploying and there was difficulty in removing the shaft.Reportedly stent was fractured and twisted.The procedure was completed using another device.Patient experienced mild stenosis in the region where the stent fractured.

Event Description

It was reported that during a stent placement procedure through femoral access site, the stent allegedly was difficult to advance.It was further reported that stent had difficulty in deploying and there was difficulty in removing the shaft.Reportedly stent was fractured and twisted.The procedure was completed using another device.Patient experienced mild stenosis in the region where the stent fractured.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 sample was returned for evaluation.The inner catheter was found detached from the system because an adhesive joint was found loose at the proximal end.Provided images further demonstrated hourglass like deformation of the stent inside the vessel which confirmed stent twisting.The returned system could not confirm difficult deployment, and stent fracture was not visible on the images.Therefore, the investigation leads to confirmed result for stent twisting, and inner catheter 'failure to bond' as cascading event.Based on the information available a definite root cause could not be identified.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 utilizing a 6f (2.0 mm) or larger introducer sheath.(¿) insert a 0.035 inch (0.89 mm) diameter guidewire'.The instructions for use further state: 'predilation of the lesion should be performed using standard techniques.' in regards to resistance the instructions for use state: 'if resistance is met during delivery system introduction, the system should be removed and another system should be used.', and '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 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.

• Brand Name: LIFESTENT XL VASCULAR STENT
• Type of Device: VASCULAR STENT SYSTEM
• 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: 12472694
• MDR Text Key: 271453180
• Report Number: 9681442-2021-00509
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001487
• UDI-Public: (01)04049519001487
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

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: EX061503C
• Device Lot Number: ANEP3020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/02/2022
• 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): Other
• Patient Age: 66 YR
• Patient Sex: Female