MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Model Number	G38479
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Niu stent, superficial femoral artery, drug-eluting.
Event or Problem Description
Reported by the dm via phone call the physician did a routine follow up on the patient, during the ultrasound it was discovered he device was fractured in half.The physician has intentions to cover with a new covered stent.The following has been answered- (b)(6), 28jan2022.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Did the patient require any additional procedures due to this occurrence? not yet did the product cause or contribute to the need for additional procedures? yes if yes, please specify additional procedures and provide details.Additional procedure information is not available currently.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 13602506
• Report Number: 3005580113-2022-00029
• Device Sequence Number: 5772412
• Product Code: NIU
• UDI-Device Identifier: 10827002384795
• UDI-Public: (01)10827002384795(17)201011(10)C1573052
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022
• Report Date (Section F): 02/25/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: G38479
• Device Catalogue Number: ZISV6-35-125-6-60-PTX
• Device Lot Number: C1573052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/28/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2022
• Date Device Manufactured: 01/03/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male