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

Catalog Number	1125225-23
Health Effect - Clinical Codes	Occlusion (1984); Foreign Body In Patient (2687)
Date of Event	08/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(46).The device was not returned for analysis.The investigation determined the reported difficulties, patient effect, and additional treatments appear to be related to circumstances of the procedure.The reported patient effect of occlusion is listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use as a known patient effect of coronary stenting procedures.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 identified no other similar incidents from this lot.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 procedure was to treat a lesion located in the left anterior descending (lad) coronary artery.A 2.25 x 23 mm xience alpine stent delivery system (sds) was advanced, without resistance felt, in an attempt to cross an already deployed stent.At this time it was determined that the stent implant was the wrong size for the vessel so the sds was removed.As the sds was being removed through the guiding catheter, resistance was felt at the tip of the guiding catheter and the stent implant dislodged from the balloon.The stent implant was located in the lad; therefore, buddy wires and a balloon were used to move it further down into the lad in an attempt to place the stent in the lesion and deploy it.The decision was then made not to deploy the stent but to pull the stent implant back; however, the lad became occluded due to the dislodged stent; therefore, the patient was prepared and sent for bypass surgery.The stent implant was not removed during the bypass surgery and remains in the patient.The patient is doing well.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: 5900526
• Report Number: 2024168-2016-05640
• Device Sequence Number: 22448
• Product Code: NIQ
• UDI-Device Identifier: 08717648199097
• UDI-Public: (01)08717648199097(17)190310(10)6030341
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/24/2016

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: 03/10/2019
• Device Catalogue Number: 1125225-23
• Device Lot Number: 6030341
• 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: 08/24/2016
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 127