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

Catalog Number	1125225-12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2016
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.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.Based on the information reviewed, 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 obtuse marginal.The 2.25 x 12 mm xience alpine stent delivery system (sds) was being advanced to the lesion and resistance was felt due to heavy calcification.After the failed attempt to cross, resistance was also felt during removal of the sds.The stent implant dislodged from the balloon into the circumflex.Attempts to retrieve the stent implant failed and the stent remains in the circumflex.It is unknown if the stent implant was implanted or crushed to the vessel wall.The vessel was left untreated.The patient is doing well post-procedure.There was no clinically significant delay in the procedure reported.No additional information was reported.

• 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: 6030458
• Report Number: 2024168-2016-06942
• Device Sequence Number: 1079221
• Product Code: NIQ
• UDI-Device Identifier: 08717648199066
• UDI-Public: (01)08717648199066(17)190124(10)6011841
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/14/2016

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: 01/24/2019
• Device Catalogue Number: 1125225-12
• Device Lot Number: 6011841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2016
• Initial Report FDA Received Date: 10/14/2016
• 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