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

Model Number	G56965
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
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: nin ¿ stent renal e3) occupation: lab manager g1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: "the device would not cross the calcified lesion." additional information received 14feb2019: the balloon did not get stuck in the lesion it just simply did not cross it.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.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation was based on event description, returned device, and image review.It was reported that the device would not cross the calcified lesion.No harm reported.The complete device was returned.An investigation revealed no damages to the device, nor to the distal tip of the catheter and the stent was still correctly loaded on to the deflated balloon.The 2 angiographic images submitted for review do demonstrate an irregular calcified appearing severe stenosis involving the proximal left subclavian artery with what appears to be a crossing catheter, extending across the lesion.There is no comment in the complaint report if there was difficulty negotiating the crossing catheter across this area or if a pre-implantation angioplasty was performed prior to attempting to advance the balloon expandable stent across the lesion.But if so, way to help circumvent this scenario would be dilating the lesion again, or changing the wire guide or the guiding catheter/introducer as described in the ifu.There is no discussion in the complaint report why neither of these maneuvers were utilized.In addition, in the ifu for the 414 rx renal balloon expandable stent, a listed contraindication for use of the stent is "patients who have stenosis that cannot be dilated to permit passage of the stent." no evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8353138
• Report Number: 3002808486-2019-00232
• Device Sequence Number: 19133678
• Product Code: NIN
• UDI-Device Identifier: 10827002569659
• UDI-Public: (01)10827002569659(17)210531(10)E3731975
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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 Expiration Date: 05/31/2021
• Device Model Number: G56965
• Device Catalogue Number: FORX414-14-80-7-16
• Device Lot Number: E3731975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Distributor Facility Aware Date: 02/06/2019
• Device Age: 8 MO
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR