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

Model Number	EX062003CL
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260); Migration or Expulsion of Device (1395); Misfire (2532); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional 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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).
Event or Problem Description
It was reported that during a stent placement procedure, the device allegedly came out of the sheath and ended up in the common iliac artery opposite side of the access side.It was further reported that the device allegedly broke.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure, the device allegedly came out of the sheath and ended up in the common iliac artery opposite side of the access side.It was further reported that the device allegedly broke.There was no reported patient injury.
Additional Manufacturer Narrative
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 physical sample was not returned.Provided images demonstrate the delivery system outside patient with a broken force transmitting joint; the deployed stent is visible but one end is fractured off and missing.The investigation leads to confirmed result for break of a force transmitting joint leading to partial deployment, and stent fracture.Images demonstrating the mal positioned stent fragment in the iliac artery were not provided.Therefore, the investigation is conformed for the reported issues.A definitive root cause could not be determined based upon the available information.Labeling review: current version of instruction for use supplied with this product: '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 pta the instruction for use state: 'predilation of the lesion should be performed using standard techniques.' in regards to accessories the instruction for use state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath insert a 0.035¿ guidewire'.Holding and handling of the system throughout deployment was found sufficiently described; in particular the instruction for use state: 'gently hold the stability sheath at or proximal to the orange marking and maintain it straight and under tension throughout the procedure.' h10: d4 (expiry date: 06/2023), g3.H11: g1, 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 : device not returned.

• Brand Name: LIFESTENT SOLO VASCULAR STENT
• Common Device Name: 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: 14344239
• Report Number: 9681442-2022-00149
• Device Sequence Number: 20399535
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANFT1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown