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

Catalog Number 1800400-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Too Soft/Flexible (4007)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event - date of event estimated.(b)(4).The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The two additional xience skypoint stents referenced are being filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat the right coronary artery (rca).The lesion was pre-dilated with a 3 mm balloon at 18 atmospheres per standard practice.A 4.0x48 xience skypoint stent, a 4.0x23 mm xience skypoint stent and a 4.0x12 mm xience skypoint stent were implanted.Post dilatation was performed with a 5 mm balloon at 24 atmospheres.On a post market evaluation (pme) survey, the physician indicated the flexibility of the undeployed stent and ability to recapture the undeployed stent in the guiding catheter as not satisfying.Reportedly, the 4.0x12 xience skypoint sds balloon was difficult to completely deflate and there may have been an incorrect contrast ratio of 50/20.The balloon only partially deflated and was withdrawn inflated.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not reported.It was reported that the contrast mixture used during the procedure was 50/20.It should be noted that the xience skypoint instructions for use (ifu) states: use contrast diluted 1:1 with heparinized normal saline.In this case, it is unknown if the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficult to remove, deflation problem, and material too soft/flexible.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

N/a.

Manufacturer Narrative

N/asubsequent to filing the previous report, it was noted that the following information was inadvertently left off of the report: d4: lot number.D4: expiration date.H4: device mfg date.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 14649478
• MDR Text Key: 293957734
• Report Number: 2024168-2022-06206
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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,Followup,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800400-12
• Device Lot Number: 2030741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: 4.0X23 MM XIENCE SKYPOINT STENT; 4.0X48 XIENCE SKYPOINT STENT