MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX; STENT, CORONARY, DRUG-ELUTING

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The physician in this case consented to participate in the survey but did not consent to be contacted regarding the information provided and wished to remain anonymous, therefore information for facility and city cannot be provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the endeavor resolute rx coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 25 years.In the past 12 months, the physician has used the endeavor resolute stent 100 times.20 of the smallest (2.25 x 8 mm), 50 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 30 of the largest sizes (4.00 x 38 mm) of these stents were used.It was noted that the device was used in other non-coronary procedures including 20 devices being used to treat carotid artery-ptas.The following device complaints were encountered in procedure when using the endeavor resolute product over the last 12 months: deployment difficulties were encountered in two cases with no impact on the procedure.Stent dislocation was reported in one case and resulted in no impact on the procedure.It was reported that in 10 cases the device did not perform as expected in terms of reaching the target lesion due to coronary morphology in the blood vessel.It was reported that in 10 cases the device did not perform as expected in terms of dilation of the target lesion.It was stated that this was due to type of lesion in the target vessel.

• Brand Name: ENDEAVOR RESOLUTE RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10264663
• MDR Text Key: 198564708
• Report Number: 9612164-2020-02562
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• 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