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

Catalog Number	1550400-18
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7806580
• Report Number: 2024168-2018-06498
• Device Sequence Number: 11048607
• Product Code: NIQ
• UDI-Device Identifier: 08717648227509
• UDI-Public: 08717648227509
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1550400-18
• Device Lot Number: 8042041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 98