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

Catalog Number UNK RX ALPINE

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

Patient Problem Stenosis (2263)

Event Date 03/10/2023

Event Type  Injury  

Event Description

It was reported that in 2017 a xience alpine stent was successfully implanted in the proximal left anterior descending (plad) artery.On (b)(6) 2023, the patient presented with in-stent restenosis (isr) of the implanted alpine stent and new stenosis in the left main (lm) to ostial lad.The procedure was to treat the moderately calcified, moderately tortuous lesion in the ostial lad to lm.While advancing a 3.5x33mm xience sierra drug eluting stent (des) to the lesion, resistance was noted, so a non-abbott guide catheter (gc) extension was added to assist advancement of the des, which was then successfully advanced to the lesion.After removal of the gc extension and during final positioning of the stent, the stent caught on the restenosed alpine stent, and dislodged from the balloon.The delivery system balloon was used to open the proximal 1/3 part of the stent.Then two non-abbott balloon dilatation catheters (2.0x15mm, 3.0x15mm) were used to further expand the dislodged stent.A 3.5x28mm xience sierra des was then implanted from the lm to the ostial lad overlapping the dislodged 3.5x33mm xience sierra des to complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

C4: treatment/therapy start date - estimated.D4: the unique device identifier (udi) is unknown because the part number and lot number were not provided.D6a: date of implant ¿ estimated.The device was not returned for analysis.A review of the electronic lot history record (elhr) 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 stenosis is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, 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.The other xience alpine stent mentioned in b5 is filed under a separate medwatch report number.

• 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: 16659669
• MDR Text Key: 312497996
• Report Number: 2024168-2023-03347
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ALPINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention