MAUDE Adverse Event Report: WILLIAM COOK EUROPE FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT

Model Number	G56975
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Common name: nin.Summary of investigational findings: no product returned, no imaging available and based on the limited information provided it would be inappropriate to speculate at what may or may not have caused the stent to deploy before the balloon was fully inflated.However, it is noted that the stent was successfully placed in the intended position (iliac) by use of two balloons, but the stent is indicated for use in patients with atherosclerotic disease of t he renal arteries.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: when the doctor went to deploy the stent, the stent started to flare.One end started to deploy before the balloon was fully inflated.When that happened, the stent moved past the iliac and into the aorta while partially deployed.They used 2 two additional cook balloons (g50328 and g50319) to move the stent back to the correct position and place it successfully.The doctor said the stent location was perfect at the end.This is a renal stent that he was using in the iliac.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.

• Brand Name: FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10513428
• Report Number: 3002808486-2020-00869
• Device Sequence Number: 19568237
• Product Code: NIN
• UDI-Device Identifier: 10827002569758
• UDI-Public: (01)10827002569758(17)221025(10)E3913282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 10/25/2022
• Device Model Number: G56975
• Device Catalogue Number: FORX414-14-135-7-20
• Device Lot Number: E3913282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 09/10/2020
• 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