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

Catalog Number 1120200-28

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted the device was not prepped outside of the anatomy as indicated in the xience alpine instructions for use.It should be noted that the xience alpine everolimus eluting coronary stent system instruction for use (ifu) lists device preparation to be performed prior to insertion into the anatomy.In this case, it is unknown if the ifu deviation related to incorrect stent preparation may have contributed to the reported event.The intent with prepping outside of the anatomy prior to use is to identify any defects or leaks and prevent issues during the procedure.In this case, it is unknown if the instruction for use deviation may have prevented the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation was unable to determine a conclusive cause for the reported material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.The reported migration and treatment appear to be related to operational context as it is likely the material rupture below rated burst pressure caused the stent to be under deployed which likely caused the reported stent migration and subsequent treatment.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly calcified, mildly tortuous left circumflex coronary artery.A 2x28mm xience alpine stent delivery system (sds) was not prepped outside the anatomy prior to use.The sds was advanced without resistance, and the balloon ruptured during deployment at 10 atmospheres.During removal of the sds, the stent migrated to the left main artery, so it was only partially in the target lesion.Multiple unspecified balloons and an unspecified stent were used to dilate the migrated stent and successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

• 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: 12481237
• MDR Text Key: 271688703
• Report Number: 2024168-2021-08209
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: HK
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2024
• Device Catalogue Number: 1120200-28
• Device Lot Number: 1042841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention