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); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 7 years.In the past 12 months, the physician has used the endeavor resolute stent 60 times.8 of the smallest (2.25 x 8 mm), 52 intermediate (2.25 x 12 mm to 4.00 x 34 mm) sizes of these stents were used.The following device complaints were encountered in procedure when using the endeavor resolute product over the last 12 months: stent loss was reported in 1 cases and resulted in no clinical/patient impact.It was reported that the device did not perform as expected in terms of reaching the target lesion in 5 events due to the calcification being too strong.It was stated that reaching the target lesion was not achievable despite pre-dilatation.It was reported that the device did not perform as expected in terms of dilation of the target lesion in 1 event due to the calcification being too strong.It was stated that despite pre-dilatation, the vessel did not adequately expand.

• 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: 10276758
• MDR Text Key: 199318095
• Report Number: 9612164-2020-02594
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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