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

Catalog Number	1125350-18
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2017
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: a visual inspection was performed.The reported stent dislodgement was confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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.As there were crimp marks on balloon between the markers suggesting the stent was originally positioned correctly and securely at the time of manufacture.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the heavily tortuous and heavy calcified anatomy resulting in the reported failure to advance.As the device was being withdrawn, interaction with the anatomy resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was performed to treat an occluded lesion with heavy tortuosity and heavy calcification in the distal right coronary artery (rca).A balance middleweight (bmw) guide wire was advanced to the target lesion and pre-dilatation was performed.A 3.5 x 18 mm xience alpine stent delivery system (sds) was advanced, but could not cross the target lesion.During the removal of the sds, the stent dislodged from the balloon.The physician commented that there was nothing unusual felt during retraction of the sds.Several attempts were made to snare the dislodged stent but this was unsuccessful.Using 1.5 and 20 balloons, the stent was able to be partially deployed in the mid rca, which was calcified throughout.The patient was hemodynamically stable and an intra-aortic balloon pump (iabp) was inserted and the patient was transferred to another hospital for coronary artery bypass grafting (cabg) later that day.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: 6959721
• Report Number: 2024168-2017-08312
• Device Sequence Number: 745637
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/18/2017

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: 01/29/2020
• Device Catalogue Number: 1125350-18
• Device Lot Number: 7012341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/18/2017
• 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; Disability
• Patient Age: 66 YR
• Patient Weight: 119