MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PRP35-07-150-080

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a protégé everflex with a 6fr non-medtronic sheath and non-medtronic guidewire during treatment of a long, calcified cto with dilatated area in the distal part behind of the cto in the patient¿s mid superficial femoral artery (sfa) of diameter 6-8mm.Slight tortuosity and moderate calcification are reported.Ifu was followed.Device prepped without issue.Pre-dilation was performed.The device was not passed through a previously deployed stent.No resistance was encountered during advancement of the device.No friction observed through the introducer and over the wire.It is reported that deployment difficulties were experienced.Friction was reported in the system.The outer shaft stuck in the inner shaft of the delivery system of the stent.The first segments of the stent were deployed.It was possible to get the rest of the catheter system out of the patient, but the first segments of the stent were torn down while trying to remove the catheter.The broken off stent fragment remains in the patient.Additional dilatation was performed and another protege everflex was used in the treated area.

Manufacturer Narrative

Image review: the customer was able to provide 3 cine images for evaluation.The images were reviewed and identified a partial stent deployment on each image.The tantalum spheres of the distal end of the stent were noted at the bottom portion of the identified stent.The location of the catheter shaft could not be conclusively identified.Product analysis: the protégé rx was returned for evaluation loaded inside a 6f sheath.The protégé everflex was inspected and observed the inner assembly was exposed outside of the distal rim of the outer assembly.Approximately 2cm of the inner was exposed outside of the distal rim of the outer assembly.With direct lighting applied approximately 13.5cm of the stent remained loaded the catheter shaft it was discovered stent struts were protruding out of the distal rim of the catheter outer by approximately and stretched distally approximately 0.5cm.The stent was fractured, the distal end of the stent with the tantalum markers was not present.The deployment system was loaded inside the deployment apparatus within the lab.The stent could not be deployed at less than 3 lbs of force.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a 5f sluice was inserted, followed by heparin and angiogram which showed a severe, diffuse and calcifying arteriosclerosis of the entire femoropliteal and crural current path.There is a long-distance almost complete afs closure and a closure of the 1st popliteal artery segment, with refill of the popliteal artery in the 2nd segment.P3 is open and highly stenosed.The anterior tibial artery is closed over a long distance with refilling at the foot via collaterals.Now very complex subintimal (over the entire length) recanalization of the cto, reentry is the real lumen at the level of the 2nd popliteal artery segment.A long-distance pta is performed with a 5 and 6 mm balloon (poba) over the entire length of the lesion, the initial angiogram after dilatation already shows a good result with flow-imitating dissections in the area of the entry of the reentry.For this reason a protégé everflex was used.Treatment was long stent angioplasty using protégé everflex and repeated post-dilation over the entire length with a 7 and 6 mm balloon is performed.Stent fragment observed in final angiography.Attempts were made to salvage the stent.The fragment wedged into the vessel.The procedure was completed with another dilatation and the implantation of a stent.The stent fragments were not jailed.Manual compression of the groin and application of a compression bandage.Unknown if the broken stent fragments caused any vessel injury.Patient is reported to be fine.Plan for prompt oscillography and doppler occlusion pressure measurement on the right foot as well as intra-assessment of blood circulation in the wound area 1 day post procedure.If perfusion is not significantly improved, indication for pedal retrograde recanalization of the anterior tibial artery (in hybrid surgery in itn).Clopidogrel monotherapy lifelong, bridging with clexane continues as before.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9007245
• MDR Text Key: 162334092
• Report Number: 2183870-2019-00439
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2020
• Device Catalogue Number: PRP35-07-150-080
• Device Lot Number: A560903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 09/16/2019; 11/22/2019
• Supplement Dates FDA Received: 09/19/2019; 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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: 72 YR
• Patient Weight: 100