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

Model Number	1125350-33
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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 lesion located in the mid-left anterior descending coronary artery that was heavily calcified.During use in the patient anatomy, the xience alpine 3.5 x 33 mm stent came off the balloon and had to be retrieved in the patient's arm using a snare device.There was no resistance noted prior to dislodgement.There was a delay in the procedure, however it was not clinically significant as there were no adverse patient effects.Another xience stent was successfully deployed to complete the procedure.The patient had an excellent final outcome.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: - it was initially reported that the device would not be returning for analysis.Subsequent information revealed that the device was returned for evaluation.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.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.The investigation determined a conclusive cause for the reported stent dislodgement cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the previously filed medwatch report, the device was received for evaluation.

• 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: 6565210
• Report Number: 2024168-2017-04144
• Device Sequence Number: 1082252
• Product Code: NIQ
• UDI-Device Identifier: 08717648199561
• UDI-Public: (01)08717648199561(17)190621(10)6061441
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/02/2017

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: 06/21/2019
• Device Model Number: 1125350-33
• Device Catalogue Number: 1125350-33
• Device Lot Number: 6061441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 08/02/2017
• 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