MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLX; STENT, SUPERFICIAL FEMORAL ARTERY,

Model Number PRB35-07100120V05

Device Problem Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/18/2014

Event Type  Injury  

Event Description

The protege everflex was delivered through a 90cm sheath.When sheath was advanced stent started to deploy.When the undeployed stent and stent delivery system were removed it was noticed that part of the stent was missing.A piece of protege everflex stent was located in the external iliac.After ballooning the piece it was decided to stent it.A balloon expandable stent was deployed with a great result.Flow was good post procedure.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.

Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

Event Description

Evaluation summary: the protege everflex stent delivery system (sds) was received for evaluation without any ancillary devices or cine images from the procedure.The stent was partially deployed and torn on the distal edge.The manifold assembly lock-mechanism was tight (locked) and was fully functional.The inner shaft hypotube was held securely when the thumbscrew was tightened but would move easily when the thumbscrew was loosened.The stent tear was irregular but the fracture (tear) sites were consistently at the edge of a hairpin bend.The deployment paddles were brought together and the remainder of the stent deployed easily.The retainer was appropriately positioned at full-deploy.The stent length was between 19.5 cells and 20.5 cells.The design for this stent calls for a cell length of 21 cells.

• Brand Name: PROTEGE EVERFLX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY,
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4168647
• MDR Text Key: 5088615
• Report Number: 2183870-2014-00257
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2017
• Device Model Number: PRB35-07100120V05
• Device Catalogue Number: PRB35-07100120V05
• Device Lot Number: 9863972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 76