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

Catalog Number	1125250-15
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Respiratory Failure (2484)
Date of Event	04/24/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, death is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.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 procedure was to treat a calcified lesion in the marginal coronary artery.The patient had been turned down for bypass surgery.Following pre-dilatation, a 2.5 x 18 mm xience alpine stent delivery system (sds) was being advanced to the lesion; however, one of the stent struts pulled up on the end and the sds could not cross the calcified lesion.A 2.5 x 15 mm xience alpine sds was successfully implanted.Shortly after the stent was placed the patient went into cardiac and respiratory arrest and could not be revived.An attempt to resuscitate the patient for 30 minutes was made, but was unsuccessful and the patient was declared dead.An autopsy was not performed.It was reported that the cause of death was not due to a device issue, but was procedure related as the patient was very ill with low ejection fraction (ef) function.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: 6573163
• Report Number: 2024168-2017-04213
• Device Sequence Number: 13639814
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: (01)08717648199165
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 05/17/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1125250-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/17/2017
• 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: Death
• Patient Age: 80 YR
• Patient Weight: 53