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

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

Patient Problem Vascular Dissection (3160)

Event Date 03/18/2024

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending (lad) coronary artery with moderate calcification, moderate tortuosity and 80% stenosis.Pre-dilation was performed with a 1.5x12mm and a 2.0x12mm mini trek balloon dilating catheter to 8 atmospheres.The 3.5x38mm xience alpine stent was deployed at 10 atmospheres and the stent delivery system was removed.An angiogram revealed a dissection at the distal edge of the stent.A 3.5x23mm xience alpine stent was used to treat the dissection with resulted in adequate hemodynamic flow without residual stenosis.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent 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; therefore, no product-related corrective action will be implemented in this case.The reported patient effect of dissection is listed in the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use as a known patient effect of coronary stenting procedures.

Manufacturer Narrative

The device was not returned for analysis.An exception review was performed and revealed no indication of a product quality issue.A review of the electronic lot history record (elhr) and lot level similar incident for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effect of dissection is listed in the xience v everolimus eluting coronary stent system as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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; therefore, no product-related corrective action will be implemented in this case.D4: the udi number is not known as the part and lot number were not provided.H6 - type of investigation; 4109 historical data analysis was removed.

• Brand Name: XIENCE ALPINE 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: 19148791
• MDR Text Key: 340675104
• Report Number: 2024168-2024-04895
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: 03/28/2024
• 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
• Patient Outcome(s): Required Intervention