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

Catalog Number 5F050603C

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in the left common femoral via cross over approach, the stent allegedly could not cross the bifurcation.It was further reported that the shaft was broken.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the u.S.But, it is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products.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.However, images were provided for review.The investigation of the reported event is currently underway.(expiration date: 12/2024).Device pending return.

Event Description

It was reported that during a stent placement procedure in the left common femoral via cross over approach, the stent allegedly could not cross the bifurcation.It was further reported that the shaft was broken.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: this supplemental mdr is being submitted to report that mfr rpt# 9681442-2022-00276 was a duplicate record and was opened in error.The event details are being captured under complaint file #(b)(4) and was reported to the fda under mfr rpt# 9681442-2022-00273.H10: d4 (expiration date: 12/2024), g3.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.H3 other text : device not returned.

• 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: 15400685
• MDR Text Key: 299668204
• Report Number: 9681442-2022-00276
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119897
• UDI-Public: (01)00801741119897
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/21/2022

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: 5F050603C
• Device Lot Number: ANFZ3183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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