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

Catalog Number	1125325-18
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041)
Date of Event	06/04/2017
Type of Reportable Event	Serious Injury
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 review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of hypotension and renal failure are listed in xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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 index procedure took place on (b)(6) 2017 during which a 3.25 x 18 mm xience alpine stent was implanted for treatment of an unspecified vessel.The patient was readmitted to the hospital on (b)(6)2017 for hypotension, hyperkalemia, acute renal failure and bradycardia.Angiotensin ii receptor blockers medication was stopped and so was the intravenous fluid of potassium supplemental medication.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: 6662028
• Report Number: 2024168-2017-05280
• Device Sequence Number: 1970987
• Product Code: NIQ
• UDI-Device Identifier: 08717648199448
• UDI-Public: (01)08717648199448(17)191115(10)6102661
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/22/2017

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 Expiration Date: 11/15/2019
• Device Catalogue Number: 1125325-18
• Device Lot Number: 6102661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/22/2017
• 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
• Patient Age: 81 YR
• Patient Weight: 67