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

Model Number	G38482
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Niu stent, superficial femoral artery, drug-eluting.
Event or Problem Description
Complaint received from dm via e-mail on (b)(6) 2021.As reported to customer relations: "stenting the sfa.Was able to roll the wheel back a little bit then heard a "snapping" noise.About 10mm of the 120mm stent was exposed at this point.Opened up the handle to try and bypass the wheel and manually pull the internal metal wire that runs inside the length of the zptx deployment system.This was not successful.They then tried to pull the whole system up into the sheath.So here they are pulling on the deployment system and pushing the sheath in.This caused the stent to fracture and the exposed 10mm (approximately) to be left behind in the sfa.While the remainder of the stent and deployment system, was then removed from the sheath." additional information provided by dm on (b)(6) 2021: "i¿d also like to get a zero dollar replacement sent out to replace this stent.Below is the info i have on the stent in question product description: zilver ptx stent 6mm x 120 mm 6fr, g38482, lot#c1656615, expiration:3-11-21".Additional information provided by dm on 02mar2021: "how was the procedure completed? yes.Additional information provided by dm on 09mar2021: "how was the procedure completed? they completed the procedure by placing a zptx stent over the fractured zptx stent.They then used a angioplasty balloon to post dilate both stents." patient outcome: did any section of the device remain inside the patient¿s body? yes.If yes, please describe."the partial stent was then stented over with another zptx stent.This whole area was then ballooned, the ballooning went fine, the balloon did not pop." was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.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.Patient/event info notes: did any section of the device remain inside the patient¿s body? yes.If yes, please describe."the partial stent was then stented over with another zptx stent.This whole area was then ballooned, the ballooning went fine, the balloon did not pop." was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.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.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11562898
• Report Number: 3005580113-2021-00049
• Device Sequence Number: 4297431
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)210311(10)C1656615
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021
• Report Date (Section F): 03/24/2021

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: 03/11/2021
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C1656615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 85