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

Catalog Number	1125275-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2017
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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a procedure of the multi-vessel percutaneous coronary intervention (pci) a 2.5 x 18 mm xience alpine stent was successfully deployed in the circumflex artery and a 2.5 x 18 mm xience alpine was deployed in the left anterior descending (lad) left main artery.It was determined that the area between an existing stent and the 2.5 x 18 mm xience alpine stent in the lad should also be treated.A 2.75 x 15 mm xience alpine stent delivery system (sds) was advanced but met resistance with the stent in the lad; while attempting to retract/position the device, the 2.75 x 15 mm xience alpine stent became dislodged in the anatomy.Attempts to crush the stent or balloon dilate the stent were unsuccessful as no devices could successfully cross the vessel/lad stent area.Although a procedural time delay, there was no clinical significance.The patient underwent coronary bypass of the left internal mammary artery (lima) to lad artery with a good outcome.The stent remains in the anatomy.Hospitalization was prolonged due to the surgical procedure.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: 6581820
• Report Number: 2024168-2017-04367
• Device Sequence Number: 1064686
• Product Code: NIQ
• UDI-Device Identifier: 08717648199257
• UDI-Public: (01)08717648199257(17)200216(10)7020841
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/22/2017

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: 02/16/2020
• Device Catalogue Number: 1125275-15
• Device Lot Number: 7020841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/22/2017
• 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