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

Catalog Number 1800450-23

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Perforation of Vessels (2135); Pericardial Effusion (3271); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2023 the patient underwent stenting in the right coronary artery with one xience skypoint stent.On (b)(6) 2023 the patient returned for treatment of a vessel that was not treated during the index procedure, however prior to starting the second procedure a perforation was observed in the distal left anterior descending artery and a 5mm pericardial effusion was observed via echocardiogram.Protamine was administered and the perforation improved.It is probable the adverse event is related to the index procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

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.The investigation was unable to determine any issue(s) with the device as no patient effects or device malfunction/failure mode was reported.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.B1, b2, h1: an adverse event related to the xience skypoint device did not occur d4: catalog # updated from unk xience skypoint to 1800450-23.D4: lot# updated from unknown to 2092941.D4: udi # updated from ni to (b)(4).D4: expiration date update from na to 9/21/2025.H6: device code 2993, 2135, 3271 and 4644 removed.H6: device code 3189, 2199 and 4582 added.

Event Description

Subsequent to the initially filed report, the following information was received: the adverse events are not related to the device or the procedure.The perforation and pericardial effusion were caused by a non-abbott guidewire.No additional information was provided.

• 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: 18133123
• MDR Text Key: 328072097
• Report Number: 2024168-2023-12634
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1800450-23
• Device Lot Number: 2092941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 68 KG