MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	EVD35-07-120-120
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician had intended to use a 7x120 mm everflex entrust self-expanding stent to treat a moderately calcified lesion in the mid left sfa.The lesion was 110 mm in length with 80% stenosis.The artery diameter was 6 mm with no tortuosity.The device was prepped as per the ifu.There was no damage noted to the packaging and the box was fully intact.A 6 french non-medtronic sheath and a 0.035" non-medtronic guidewire was used in the procedure.No embolic protection was used.The lesion was pre-dilated with a 5x120 admiral device.The physician did not experience resistance during advancement and excessive force was not used.It was noticed under fluoroscopy that the stent was not 120 mm in length and the stent was removed from the patient without being deployed.The box that the device was housed in had indicated a 120mm stent however the stent was 60 mm in size.Another 7x120 mm everflex entrust device was opened and deployed.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the stent received for investigation measured approximately 60mm.The printed strain relief and pouch label indicate that the entrust stent delivery system should contain a 7mm by 120mm everflex stent.Review of the manufacturing schedule revealed that a 7mm by 60mm lot was manufactured just prior to the manufacture of a476301 (7mm by 120mm).A manufacturing investigation revealed that the most likely step in the manufacturing process were the swap could occur was at tip form/trim.A single photographic image was received with the initial reported event.The image included the shelf carton with shelf carton label, stent delivery system with the printed strain relief turned to be readable, and a stent next to a radiopaque ruler.The shelf carton label and printed strain relief indicate that the entrust delivery system should deliver a 120mm stent.The stent when measured against the radiopaque rule it rests on indicates that it is a 60mm stent.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6871450
• Report Number: 2183870-2017-00405
• Device Sequence Number: 1183269
• Product Code: NIP
• UDI-Device Identifier: 00821684051467
• UDI-Public: 00821684051467
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2017

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: 06/14/2020
• Device Catalogue Number: EVD35-07-120-120
• Device Lot Number: A476301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 10/05/2017; 11/06/2017
• Initial Report FDA Received Date: 09/17/2017
• Supplement Report FDA Received Date: 11/03/2017; 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2183870-11-06-2017-001-R
• Patient Sequence Number: 1
• Patient Age: 64 YR