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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the physical resistance and stent dislodgment appear to be related to the patient anatomy.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 resistance was felt with the anatomy when advancing the 2.5x15 mm xience alpine stent delivery system (sds).While attempting to advance the sds, the stent dislodged in the patient anatomy.An unspecified xience alpine stent was implanted to complete the procedure.The following day, after the procedure, on (b)(6) 2017 a snare device was used to remove the dislodged stent from the patient anatomy.The patient is stable.There was a delay in the procedure, the patient had to have the dislodged stent snared two days after the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The investigation determined the failure to advance appears to be related to the patient anatomy.

• 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: 6412102
• Report Number: 2024168-2017-02234
• Device Sequence Number: 18970951
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: (01)08717648199165(17)180308(10)5022641
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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: 03/08/2018
• Device Catalogue Number: 1125250-15
• Device Lot Number: 5022641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/15/2017
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 83