MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550400-18

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the vessel; the delivery system was not returned to abbott vascular 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 similar incidents reported from this lot.A cine was received and reviewed by an abbott clinical specialist.The reviewer concluded that the 4.0x18 sierra stent deployed in the proximal lad migrated proximally requiring additional percutaneous coronary intervention (pci) distally, where another stent was implanted.The investigation was unable to determine a conclusive cause for the reported stent movement.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that during a procedure of the proximal left anterior descending (lad) artery, during stent deployment, the 4.0 x 18 mm xience sierra stent moved proximally, resulting in the stent implanting and missing the distal portion of the lesion.A different 4.0 x 8 mm xience sierra stent was implanted in the distal lesion segment.Excellent angiographic result was achieved.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7806580
• MDR Text Key: 117961253
• Report Number: 2024168-2018-06498
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227509
• UDI-Public: 08717648227509
• Combination Product (y/n): N
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1550400-18
• Device Lot Number: 8042041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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 Age: 63 YR
• Patient Weight: 98