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

Catalog Number EX080803C

Device Problems Entrapment of Device (1212); Misfire (2532); Detachment of Device or Device Component (2907)

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

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

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.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 products that are cleared in the u.S.The pro code and 510 k number for the lifestent vascular stent products are identified.(expiry date: 07/2022); device pending return.

Event Description

It was reported that during stent placement procedure, the stent allegedly deployed, and caught in the sheath.It was further reported that delivery handle allegedly came out from the device.There was no reported patient injury.

Manufacturer Narrative

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 returned catheter sample confirmed that the user could only partially deploy the stent.Inside the grip, the metal guiding tube was bent and visible from outside; a force transmitting component was broken as further consequence.Excessive release force must have been present during deployment leading to deformation and break of grip components.An indication for a production related issue could not be identified.In this case, the vessel was not tortuous/ calcified, and the lesion was pre dilated.Reportedly, a 5f introducer sheath was in use for access.Based on the information available the investigation is closed with confirmed result for partial stent deployment.A definite root cause for the reported event could not be determined.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 stent system.Remove the stent system as possible and replace with a new unit.' the instructions for use further state: 'predilatation of the lesion should be performed using standard techniques.' regarding introducer size the instructions for use state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.' h10: the catalog number identified in section d4 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 in d2 and g4.H10: d4 (expiry date: 07/2022), g3.H11: h6 (device, method, result, conclusion).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.H3 other text : see h10.

Event Description

It was reported that during stent placement procedure, the stent allegedly deployed and caught in the sheath.It was further reported that delivery handle allegedly came out from the device.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11062265
• MDR Text Key: 223397302
• Report Number: 9681442-2020-20112
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX080803C
• Device Lot Number: ANEU0580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other