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

Model Number 1804275-38

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 08/19/2021

Event Type  malfunction  

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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported torn balloon; however, factors that may contribute to torn balloon include, but are not limited to, interactions with other devices or interaction with lesion calcification and tortuosity.The reported leak is likely a result of the reported balloon tear.It should be noted, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.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 right coronary artery.A 2.75x38mm xience skypoint stent delivery system (sds) was prepared per the instructions for use without issues.The sds was advanced without issues; however, blood in the hypotube was noted possibly indicating a leak.The sds was removed without issues.Once outside the patient anatomy unspecified pressure was applied and a pinhole at the proximal balloon was noted.The procedure was successfully completed with a 2.75x38mm xience skypoint stent.There were no adverse patient effects and no clinically significant delay in the procedure.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: 12488687
• MDR Text Key: 271928842
• Report Number: 2024168-2021-08252
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233203
• UDI-Public: 08717648233203
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: 1804275-38
• Device Catalogue Number: 1804275-38
• Device Lot Number: 1040741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 102