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

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Age: average age. Sex: majority gender. Date of event: date of publication journal article: vascular responses to coronary calcification following implantation of newer-generation drug-eluting stents in humans: impact on healing journal: european heart journal year: 2019 ref: doi:10. 1093/eurheartj/ehz850. If information is provided in the future, a supplemental report will be issued.

Event Description

Resolute integrity drug eluting stents were among a number of drug eluting stents used in a study involving autopsy cases which analysed vascular responses to coronary calcification following implantation of newer-generation drug-eluting stents in humans. Out of 134 stents analysed, 29 were resolute integrity stents. Lesions treated included the left main, left circumflex, left anterior artery descending and right coronary artery. Adverse events experienced included stent thrombosis, restenosis, dissection, stent related death, non- stent related cardiac death and non-cardiac death, explant due to heart transplant death and target lesion revascularization. Malfunctions reported included stent fracture and strut malapposition which were assessed through imaging. It was also reported that a (b)(6) year old patient with a medical history of hypertension, diabetes and coronary artery disease had a resolute integrity des implanted. One year post implant the patient died. Low power images of stented sections for this patient demonstrated in-stent restenosis with a large medial tear in a severely calcified artery. Strut malapposition was also observed.

Manufacturer Narrative

Additional information: medtronic devices were not related to stent related deaths. There were no cases with stent related deaths after medtronic devices in this study population. There is no stent thrombus and dissection in medtronic devices. Target lesion revascularisation cannot be evaluated in the autopsy study since this is not end point in the autopsy study and only this information can be collected by clinical phases. In-stent restenosis was found in 7 lesions with medtronic devices but there are no significant differences between devices. The presence of calcification in underlying eccentric plaque affected medial tear rather than the type of stent because the stent could be expanded only toward non-calcified area. 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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9584879
• Report Number: 9612164-2020-00207
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 63 YR