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

Catalog Number	1125275-12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2016
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.(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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
User facility medwatch: during delivery and deployment of stent, guide wire came out of coronary artery.Stent stripped off of delivery catheter.Multiple angulations failed to find undeployed stent in artery.Flouro scan was negative.Unable to locate stent in room.Additional reported information indicates that the 2.75x12 mm xience alpine stent implant was confirmed to be on the stent delivery system (sds) prior to inserting the sds into the patient anatomy.It is not known if the balloon was inflated in an attempt to deploy the stent prior to the guide wire coming out of the coronary artery.There is a definite possibility the stent remains somewhere in the patient anatomy but was not able to be located.The target lesion was ultimately treated with another stent.The patient was fine.There was no clinically significant delay in the 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: 5914886
• Report Number: 2024168-2016-05813
• Device Sequence Number: 403444
• Product Code: NIQ
• UDI-Device Identifier: 08717648199240
• UDI-Public: (01)08717648199240(17)180901(10)5081941
• 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): 08/30/2016

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: 09/01/2018
• Device Catalogue Number: 1125275-12
• Device Lot Number: 5081941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2016
• Initial Report FDA Received Date: 08/30/2016
• 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: Other
• Patient Age: 58 YR
• Patient Weight: 127