MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number EVX35-06-150-120

Device Problems Activation, Positioning or Separation Problem (2906); Compatibility Problem (2960); Material Deformation (2976)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

A physician was implanting everflex entrust stents for treatment of a plaque lesion with 60-70% stenosis in the right superficial femoral artery.There was mild calcification.The lesion was pre-dilated with a 3.0mm balloon.The ifu was followed.It was reported with the first stent there was no resistance encountered during delivery to the lesion and no excessive force was used.When the physician removed lock-pin, thumbwheel issues were encountered and resistance was felt during releasing the stent but the stent was deployed.The target lesion was long and another everflex entrust was used and the same issue occurred.When the third stent was used in the proximal region of the sfa, the stent delivery system captured a non-medtronic wire so the physician decided to take out the whole stent system with wire and change another new wire to re-enter.The same problem then occurred, there's resistance on thumbwheel (the lock-pin is fully removed), the stent delivery mechanism was abnormal and resulted in stent elongation.As a result of the deformation the physician carefully deployed the stent with thumbwheel, stent was deployed in sfa, no further actions taken.Although there was stent elongation for the 3rd stent but it was deployed in the sfa and it covered the target lesion.No patient injury was reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Product analysis the device was returned with the red safety tab out of the device, there was no stent in the device and there was a guidewire stuck in the device, the gold outer sheath was observed protruding from the red safety lock space, the guidewire was measured and measured as 0.018¿, the handle was dismantled, and the pull cable was observed to be snapped on the deployment wheel.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18948320
• MDR Text Key: 338345114
• Report Number: 2183870-2024-00093
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVX35-06-150-120
• Device Lot Number: B583218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Date Manufacturer Received: 02/22/2024
• Date Device Manufactured: 06/21/2023
• 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 Age: 76 YR
• Patient Sex: Female