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

Model Number	G56968
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Stenosis (2263)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).D2) common name: stent, renal product code: nin d4) catalog# forx414-14-135-5-16 g1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: they were able to track a cook.014 roadrunner and were able to pass two 14 lp cook balloons to predilate the vessel.When they went in with the balloon expandable stent, it would not pass.This was the case first for the 5 x 20 (b)(4) and then for the 5 x 16 (b)(4).Neither would pass.They successfully completed the procedure with a boston scientific balloon expandable stent.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable (b)(4).Summary of investigational findings: no product was returned and no imaging was provided.Therefore, based on the limited information provided it would be inappropriate to speculate at what may or may not have caused the difficulties in advancing the balloon expandable stent device over the wire guide.However, it is noted that the complaint report does not mention any placement/advancement through a guiding catheter/introducer, as referenced in the ifu.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7340666
• Report Number: 3002808486-2018-00340
• Device Sequence Number: 16437387
• Product Code: NIN
• UDI-Device Identifier: 10827002569680
• UDI-Public: (01)10827002569680(17)191017(10)E3506863
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56968
• Device Catalogue Number: FORX414-14-135-5-16
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/26/2018
• Device Age: 16 MO
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1