MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE

Device Problem Difficult to Advance (2920)

Patient Problem Stenosis (2263)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

D4: the udi is unknown due to the part/lot number was not provided.D6.Date of implant is estimated as (b)(6) 2014.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional vision device referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported that a 3x18 mm vision stent had been implanted in the proximal / mid left anterior descending (lad) coronary artery in (b)(6) 2014.In (b)(6) 2014, restenosis was noted in the vision stent and a 3x28 mm xience stent was implanted as treatment.On (b)(6) 2024, restenosis was noted in the 3x28 mm xience stent, as well as some new disease distal to the stent.An additional stenting procedure was performed with implant of a 3x18 mm xience skypoint stent, implanted inside the re-stenosed stent and extending out the distal end into the mid lad.A second 2.75x12mm xience skypoint stent was advanced to the lesion, but was unable to cross the proximal previously implanted 3x28 xience stent.A replacement 2.75x18 xience skypoint stent was then advanced and successfully implanted in the mid-distal lad and the procedure was completed.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) and lot level similar incident review for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.The reported patient effect of stenosis is listed in the xience everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the stenosed xience stent resulting in the reported difficult to advance.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18812979
• MDR Text Key: 336616877
• Report Number: 2024168-2024-02615
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 3X18 VISION STENT
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG