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

Catalog Number	1074300-23
Medical Device Problem Codes	Defective Device (2588); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Guide cath: turnpike/guidezila, stent: xience xpedition, guide wire: xtra s'port.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 reported patient effect of ischemia is listed in the xience xpedition 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xtra s'port guide wire referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2019, during a planned staged procedure in the proximal right coronary artery (rca), 2 xience xpedition stents were successfully implanted, using an xtra s'port guide wire.During removal of the guide wire, resistance was noted with one of the implanted stents and an attempt was made to remove the guide wire by using a non-abbott micro catheter and guide extension.However, this was not successful and force was applied.The distal stent in the proximal rca was shortened and the guide wire broke and remains in the vessel.Timi flow was reduced to 1.Multiple unsuccessful attempts were made to re-open the vessel, but timi flow remained at 1.No additional intervention was performed, and the patient was transferred to the intensive care unit.The patient was noted to be recovering well.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 8335488
• Report Number: 2024168-2019-01078
• Device Sequence Number: 11343386
• Product Code: NIQ
• UDI-Device Identifier: 08717648162350
• UDI-Public: 08717648162350
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 10/09/2021
• Device Catalogue Number: 1074300-23
• Device Lot Number: 8092741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/13/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 59