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

Catalog Number 1011706-12

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effect of intimal dissection is listed in the xience prime small vessel (sv), everolimus eluting coronary stent system, instructions for use (ifu) as a known patient effect of coronary stenting procedures.A review of the xience prime label attached to the lot history record for this lot was conducted indicating a manufacturing date of 02-may-2017 with an expiration date (use by date) of 01-may-2020.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2020.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the xience prime sv, ifu states: note the product use by (expiration) date specified on the package.It is unlikely the ifu deviation of device expiration issue contributed to the reported patient effects.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 of the device.

Event Description

It was reported that the procedure was to treat the obtuse marginal (om) coronary artery with heavy calcification and moderate tortuosity.The lesion was pre-dilated and the 2.25x12 mm xience prime stent was deployed.A distal edge dissection was noted and another xience prime stent was used to cover the dissection.There were no adverse patient sequela.No additional information was provided.

• Brand Name: XIENCE PRIME SV 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: 10502647
• MDR Text Key: 205959818
• Report Number: 2024168-2020-07453
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 1011706-12
• Device Lot Number: 7042441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention