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

Model Number	1125225-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
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.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 did not indicate a lot specific quality issue.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 99% stenosed, heavily calcified, and heavily tortuous severely angulated lesion in the circumflex artery.The patient had successfully intervention with an unknown stent on (b)(6) 2017.The patient felt angina on (b)(6) 2017 and was sent to the cath lab.Following pre-dilatation with multiple balloon catheters, a 2.25x15mm xience alpine stent delivery system (sds) was advanced.However, resistance with the angular portion of the artery was felt and the device could not completely reach the lesion.An attempt to remove the sds was made, but a tug was felt.The sds was removed and it was noticed that the stent was missing.Reimaging was performed and it was thought that the stent was caught between the left anterior descending artery and the circumflex artery.A small size balloon catheter was advanced in an attempt to deploy the stent; however, the stent was crimped and the balloon could not be placed in the stent.An attempt to snare the stent was made, but failed.The patient was sent to another cath lab and the stent was successfully retrieved with a snare.The patient was treated with additional stents and is doing fine.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: 6715166
• Report Number: 2024168-2017-05910
• Device Sequence Number: 19144245
• Product Code: NIQ
• UDI-Device Identifier: 08717648199073
• UDI-Public: (01)08717648199073(17)190202(10)6012541
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 07/14/2017

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: 02/02/2019
• Device Model Number: 1125225-15
• Device Catalogue Number: 1125225-15
• Device Lot Number: 6012541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/14/2017
• 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