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

Device Problems Burst Container or Vessel (1074); Activation, Positioning or Separation Problem (2906)

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.Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.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 drug-eluting coronary stent system.Survey results from an interventional cardiologist in practice 12 years.In the past 12 months the physician has used the endeavor resolute rx drug-eluting stent 150 times.35 of the smallest (2.25 x 8 mm), 75 of the intermediate (2.25 x 12 mm to 4.00 x 24 mm) and 40 of the largest (4.00 x 30 mm) sizes were used.It was also noted that inthe last 12 months the endeavor resolute drug-eluting coronary stent system was used in non-coronary procedures including 60 peripheral artery disease treatments.The following complications adverse events/effects were encountered in the using the product over the last 12 months: two balloon rupture events, related to a pre-existing condition or comorbidity one rash event, related to a pre-existing condition or comorbidity it was reported that the device did not perform as expected in terms of reaching the target lesion in 5 cases due to it not being possible to intervene the lesion.It was reported that the device did not perform as expected in terms of dilation of the target lesion in 3 cases due to the lesion being too calcified.It was reported that the device did not perform as expected in terms of the ability to achieve thrombolysis in myocardial infarction (timi) flow 3 in 2 cases due to pronounced thrombosis.

• 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: 10501388
• MDR Text Key: 207738522
• Report Number: 9612164-2020-03382
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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: 08/28/2020
• 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