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

Catalog Number	1550300-28
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.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 reported patient effect of vasoconstriction (coronary artery spasm) is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device met resistance with the patient¿s anatomy during removal causing the reported difficulty to remove and subsequent material separation with the patient effects of vasoconstriction and foreign body in patient.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient underwent a coronary procedure on (b)(6) 2019.A 3.0 x 28 mm xience sierra stent was implanted in the mid left anterior descending (lad) artery.During removal of the stent delivery system, spasm occurred in the radial artery.The stent delivery system was unable to be removed and the marker band separated.The delivery system was removed; however, the marker band remained in the patient anatomy.A vascular surgeon was consulted, and it was deemed a greater risk to the patient to undergo a surgical removal of the separated segment.The separated segment remains in the patient anatomy.The patient reported feeling pain at the site where the device separation occurred, but feels no pain at this time.The patient's physician has suggested she have a magnetic resonance image (mri) for a non-related health issue, but the patient is concerned that the magnet may affect the marker band.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9468349
• Report Number: 2024168-2019-14522
• Device Sequence Number: 11539173
• Product Code: NIQ
• UDI-Device Identifier: 08717648227288
• UDI-Public: 08717648227288
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2019
• Device Catalogue Number: 1550300-28
• Device Lot Number: 8091741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 50