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

Catalog Number	1125300-18
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis (2100)
Date of Event	04/06/2017
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.The device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The deflation issue and difficulties removing the device were not confirmed.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 from this lot.The reported patient effect of thrombosis is listed in the xience alpine everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported deflation issues and difficulty removing the device.Furthermore, a conclusive cause for the reported cardiac arrest and thrombosis, and the relationship to the device, if any, cannot be determined.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 the patient presented with angina and that the procedure was to treat a lesion in the non-tortuous, mildly calcified, 90% stenosed mid left anterior descending (lad) coronary artery.A 3.00 x 18 mm xience alpine stent delivery system (sds) was selected for the procedure.The sds was advanced with no resistance to the lesion and the balloon was inflated to deploy the stent.Once the stent was successfully deployed the balloon would not fully deflate.When they pulled the sds back the partially deflated balloon got hung up in the unspecified guiding catheter and they were removed from the anatomy as one unit.Two days later the patient was readmitted to the hospital in cardiac arrest and needed to be defibrillated three times in order to bring her heart back into normal rhythm.Angiography revealed a thrombus in the stent that was implanted on (b)(6) 2017.It was confirmed that the patient was compliant with dual antiplatelet drug therapy (dapt) after the procedure that was performed on (b)(6) 2017.An additional xience alpine stent was implanted and the ejection fraction went from 60% to 40%.The patient is recovering and is scheduled to be discharged the week of (b)(6) 2017.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 6540347
• Report Number: 2024168-2017-03844
• Device Sequence Number: 16267270
• Product Code: NIQ
• UDI-Device Identifier: 08717648199356
• UDI-Public: (01)08717648199356(17)200104(10)6121361
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: 01/04/2019
• Device Catalogue Number: 1125300-18
• Device Lot Number: 6121361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/03/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 94