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 30 years.In the past 12 months, the physician has used the resolute integrity stent 500 times.40 of the smallest (2.25 x 8 mm), 380 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 80 of the largest sizes (4.00 x 38 mm) 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: five coronary artery occlusion events with 2 being related to a pre-existing condition or comorbidity and 3 directly related to the device itself.It was stated that the coronary artery occlusion events were associated specifically with the use of the device because they were acute events and had high thrombogenicity.5 coronary artery dissection events with 3 being related to a pre-existing condition or comorbidity and 2 directly related to the de vice itself.It was stated that the coronary artery dissection events were associated specifically with the use of the device because the vessels implicated were fragile.10 incomplete stent apposition events which were all directly related to the device itself.It was stated that the incomplete stent apposition events were associated specifically with the use of the device because there was a mismatch between the vessels and the stents.This was detected due to the presence of a cto.Post dilation was then performed.It was reported that none of the coronary artery dissection, coronary artery occlusion or incomplete stent apposition events directly related to the device required any medical or surgical intervention.It was also mentioned that none of these events were previously reported to medtronic.

Manufacturer Narrative

Additional information: 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.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10246048
• MDR Text Key: 198679497
• Report Number: 9612164-2020-02484
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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