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

Catalog Number	1125300-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: guide wire: balance middleweight; guide cath: guideliner; stents: 4x12mm (x2), 3.5x28mm, 3x38mm, 2.5x23mm, 2.75x15 mm xience alpine; intravascular ultrasound.The stent remains in the anatomy and the delivery system 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 identified no other similar incidents from this lot.The investigation determined a conclusive cause for the reported wall apposition issue could not be determined.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.The 3.5x28mm xience alpine stent is filed under a separate medwatch report.
Event or Problem Description
It was reported that the high risk patient presented for left heart angiography, with multi-vessel coronary artery disease.An impella, left ventricle assist device, was placed for support.Multiple non-abbott balloons were used and stents implanted in the obtuse marginal arteries and septal perforator branch.A 3.0x38mm xience alpine (xa) stent was implanted in the mid left anterior descending coronary artery (lad), followed by a 2.75x15mm xa in the distal lad, two xa (4.0x12mm, 3.5x28mm) stents in the proximal lad and a 2.5x23mm xa stent in the 1st diagonal artery.Upon intravascular ultrasound (ivus) exam, the 3.5x28mm xa in the proximal lad was noted to be compressed and shortened.No treatment was provided.The 3.0x38mm xa in the mid lad was mildly under-expanded and required additional dilatation.The procedure was deemed successful and the impella device was removed.There was no additional information 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: 6974496
• Report Number: 2024168-2017-08428
• Device Sequence Number: 13677928
• Product Code: NIQ
• UDI-Device Identifier: 08717648199394
• UDI-Public: 08717648199394
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: 12/07/2019
• Device Catalogue Number: 1125300-38
• Device Lot Number: 6112941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/24/2017
• 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
• Patient Age: 58 YR
• Patient Weight: 72