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

Catalog Number	1125275-23
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/03/2016
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 and additional treatments 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 of the reported lot 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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the 2.75x23mm xience alpine stent delivery system (sds) was unable to cross an older stent in the proximal left circumflex due to the calcified anatomy and the older stent.The sds was being retracted from the anatomy when the stent dislodged into the left main and then into the aorta.The dislodged stent was successfully snared out, but the doctor could not tell if part of the dislodged stent might have remained in the older stent.With the help of a guideliner, a non-abbott 3.0x32 stent was able to cross the older stent.The longer, non-abbott stent was used to treat the intended lesion and the potential fragment of the dislodged stent.There was no damage noted to the older stent in the circumflex.The patient was reportedly fine.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: 5880740
• Report Number: 2024168-2016-05464
• Device Sequence Number: 16413249
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: (01)08717648199271(17)180623(10)5061641
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/16/2016

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: 06/23/2018
• Device Catalogue Number: 1125275-23
• Device Lot Number: 5061641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/16/2016
• 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
• Patient Age: 69 YR
• Patient Weight: 77