MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-07-150-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the protégé everflex was returned for evaluation.Procedure notes and an event log hard copy was included with the device.It was discovered a spider fx was loaded in the protégé everflex catheter.No other ancillary devices were included.The protégé everflex was inspected.The tip and the inner tubing of the catheter was returned.The retainer was present on the inner tubing.The inner tubing was fractured approximately 17.5cm from the distal tip, between the proximal end of the retainer bond and the nylon spline segment.The fracture was radial and the fracture face was ductile.Narrowing of the tubing was observed at the proximal end.No other portion of the protégé everflex was returned.The spider fx was loaded inside the catheter segment with the filter exposed outside of the distal end of protégé everflex.Procedure notes and event log documents were received and reviewed.Procedure performed included successful recanalization of long segment right sfa occlusion with directional atherectomy using a hawk one m atherectomy catheter, drug-coated balloon angioplasty predilatation, and adjunctive 7mm x 150mm and 7mm x 200mm protege stent placement.Successful 9mm x 40mm protege stent placement to the proximal right external iliac artery.Applicable log entries: 11:52 am (b)(6) 2018 other supply event - embolic protection 5 x 320 spider fx - inserted.Advanced to right popliteal artery and deployed.Delivery system removed 12:12 pm 8/16/18 stent inserted - stent protege 6 x 200 x 120 12:13 pm (b)(6) 2018 stent deployment ¿ rt.Sfa protégé stent 12:16 pm (b)(6) 2018 stent delivery system removed - stent protege 6 x 200 x 120 12:17 pm (b)(6) 2018· stent inserted - stent protege 7 x 150 x 120 everflex 12:19 pm (b)(6) 2018 stent deployment - stent deployed in the lower extremity.Rt.Sfa protege 7 x 1 50.12:20 pm (b)(6) 2018 stent delivery system removed - stent protege 7 x 150 x 120 everflex 12:21 pm (b)(6) 2018 other supply event - embolic protection 5 x 320 spider fx ¿ removed 12:25 pm (b)(6) 2018 guidewire inserted - guide wire wholey j 260cm.035 hi-torque modified j sytem 12:33 pm (b)(6) 2018 stent inserted - stent protege 9 x 40 x 120 self expanding 12:34 pm (b)(6) 2018 stent deployment ¿ no supply selected ¿ protégé 12:34 pm (b)(6) 2018 stent delivery system removed no complications were reported within the procedure or event log.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used the protégé everflex, with a spider fx 5mm and 6f non-medtronic sheath, to treat a severely calcified cto with moderate vessel tortuosity in the right superficial femoral artery.The device was prepped per ifu with no issues identified.The lesion was pre-dilated with a 3mm pta.The device did not pass through a previously deployed stent, no resistance was experienced and no excessive force was used.It was reported that, after successful deployment of the stent, the stationary part of the delivery system broke off, detaching at the proximal part of the stent delivery system.The detached component was captured in the spider fx and removed from the patient.No patient injury was reported.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7876164
• Report Number: 2183870-2018-00440
• Device Sequence Number: 2076471
• Product Code: FGE
• UDI-Device Identifier: 00821684060155
• UDI-Public: 00821684060155
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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 Expiration Date: 07/17/2021
• Device Catalogue Number: PRB35-07-150-120
• Device Lot Number: A677862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 69