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	Foreign Body In Patient (2687)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Indication for use.The device was not returned for analysis.The xience alpine everolimus eluting coronary stent system, domestic, instructions for use (ifu), states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.It is unknown if the ifu deviation contributed to the reported event.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined that the reported failure to advance, stent dislodgement, foreign body in patient and subsequent treatment appear to be related to circumstances of the procedure.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 the procedure was to treat the heavily calcified proximal to mid saphenous vein graft (svg) in the right coronary artery (rca).Thrombectomy was performed followed by heavy pre-dilatation with balloon catheters.The 2.5x18mm rx alpine stent delivery system (sds) was advanced; however, would not cross the lesion after several attempts.During retraction, the stent dislodged from the balloon.An attempt was made to advance a balloon catheter into the dislodged stent; however this was unsuccessful.No attempts were made to snare the dislodged stent and it remains in the proximal svg.No further attempts were made to treat the lesion as the patient was in stable condition.There was no clinically significant delay in the procedure and no adverse patient sequela.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: 6948742
• Report Number: 2024168-2017-08204
• Device Sequence Number: 11040760
• Product Code: NIQ
• UDI-Device Identifier: 08717648199172
• UDI-Public: 08717648199172
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/13/2017

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: 06/12/2020
• Device Catalogue Number: 1125250-18
• Device Lot Number: 7053161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/13/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 68