MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 30MM 4.0MM PALMAZ BALLOON EXPANDABLE STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	11/10/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was identified during a recent clinical evaluation review/literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The device is a palmaz stent and the catalog is available, but the lot number is not available.The article was published in 195 and no additional information is available.The device remains implanted and is not available for evaluation.A copy of the publication is attached to this report.The citation is as follows: law, m.A., shamszad, p., nugent, a.W., justino, h., breinholt, j.P., mullins, c.E., & ing, f.F.(2010).Pulmonary artery stents: long-term follow-up.Catheterization and cardiovascular interventions : official journal of the society for cardiac angiography & interventions, 75(5), 757¿764.(b)(4).As reported in the literature article by ,law, m.A., shamszad, p., nugent, a.W., justino, h., breinholt, j.P., mullins, c.E., & ing, f.F.(2010).Pulmonary artery stents: long-term follow-up.Catheterization and cardiovascular interventions : official journal of the society for cardiac angiography & interventions, 75(5), 757¿764.Https://doi.Org/10.1002/ccd.22356, one patient with a palmaz 3 series p308 stent developed hemodynamically significant restenosis.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.According to the article, branch pulmonary artery (pa) stenosis is commonly associated with many congenital heart defects.Unilateral stenosis causes significant imbalance in right versus left pa blood flow [1] and potentially worsen pulmonary insufficiency in patients with repaired tetralogy of fallot [2].With limited human data, recent reports in animal models also suggest that stenosis can worsen pulmonary valve insufficiency [3].The long-term sequelae of branch pa stenosis with pulmonary insufficiency result in rv dysfunction, ultimately increasing the risk of ventricular arrhythmias and sudden death.Restenosis is a known potential adverse event associated with stent implantation and is often associated with the progression of disease.Additionally, the use of the palmaz stent is off label usage as the device is not indicated for pediatric usage.According to the safety information in the instructions for use ¿the palmaz xl balloon-expandable transhepatic biliary stent is indicated for palliation of malignant neoplasms in the biliary tree.¿ the limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported in the literature article by ,law, m.A., shamszad, p., nugent, a.W., justino, h., breinholt, j.P., mullins, c.E., & ing, f.F.(2010).Pulmonary artery stents: long-term follow-up.Catheterization and cardiovascular interventions : official journal of the society for cardiac angiography & interventions, 75(5), 757¿764.Https://doi.Org/10.1002/ccd.22356, one patient with a palmaz 3 series p308 stent developed hemodynamically significant restenosis.

• Brand Name: 30MM 4.0MM PALMAZ BALLOON EXPANDABLE STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11753847
• Report Number: 9616099-2021-04485
• Device Sequence Number: 3157998
• Product Code: FGE
• UDI-Device Identifier: 20705032057292
• UDI-Public: 20705032057292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K911581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P308
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/30/2021
• 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: Hospitalization; Life Threatening