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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Occlusion (1984)

Event Type  Injury  

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 resolute integrity rx coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 12 years.In the past 12 months, the physician has used the resolute integrity stent 35 times.5 of the smallest (2.25 x 8 mm), 25 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 5 of the largest (4.00 x 38 mm) sizes of these stents were used.The following complications adverse events/effects were encountered in the using the resolute integrity product over the last 12 months: 3 coronary artery spasm events which were directly related to the device itself.It was stated that the coronary artery spasm events were associated specifically with the use of the device due to the coronary vessel diameter being overestimated.One of the 3 coronary artery spasm events required medical or surgical intervention.2 coronary artery dissection events which were directly related to the device itself.It was stated that the coronary artery dissection events were associated specifically with the use of the device due to the presence of massive calcification within the coronary artery.Both coronary artery dissection events required medical or surgical intervention.It was noted that none of the events above that were directly related to the device itself had previously been reported to medtronic.

• Brand Name: RESOLUTE INTEGRITY 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: 10250034
• MDR Text Key: 198096197
• Report Number: 9612164-2020-02502
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Outcome(s): Required Intervention