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

Catalog Number	1125250-18
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	03/28/2017
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 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 similar incidents from this lot.It is possible that during removal resistance was met with the heavily calcified anatomy resulting in the reported difficulty to remove; however, this cannot be confirmed.Additionally, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, ventricular arrhythmia is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined a conclusive cause for the reported difficulties 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 patient presented with unstable angina and the procedure was to treat a lesion in the non-tortuous, heavily calcified, mid left anterior descending (lad) coronary artery.A 2.50 x 18 mm xience alpine stent delivery system (sds) was selected for the procedure.After the successful deployment of the stent in the lesion, resistance was felt during removal of the sds from the anatomy.At some point during or after the procedure the patient experienced ventricular fibrillation (vfib) which necessitated the use of a defibrillator to shock the heart back into sinus rhythm.The patient was reported to have recovered and doing fine.In the physician's opinion, the resistance felt during removal of the sds did not have anything to do with the ventricular fibrillation that the patient experienced.No additional information 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: 6512013
• Report Number: 2024168-2017-03479
• Device Sequence Number: 10913226
• Product Code: NIQ
• UDI-Device Identifier: 08717648199172
• UDI-Public: (01)08717648199172(17)180519(10)5050841
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/21/2017

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: 05/19/2018
• Device Catalogue Number: 1125250-18
• Device Lot Number: 5050841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/21/2017
• 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: Required Intervention