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

Catalog Number	1125350-38
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation (2001); Heart Failure (2206)
Date of Event	06/15/2017
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.Concomitant products: dilatation catheter: 2.5 x 20 mm,3.0 x 12 mm, 4.0 x 12 mm(x2), 5.0 x 12 mm euphora; stent: 2.5 x 33 mm, 3.0 x 38 mm, 4.0 x 18 mm, 4.0 x 33 mm xience alpine.The device was not returned for evaluation.The reported patient effect of perforation is listed in xience alpine everolimus eluting coronary stent systems 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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The graftmaster device referenced is being filed under separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a total occlusion in the right coronary artery (rca).A total of five xience alpine stents (2.5 x 33 mm, 3.0 x 38 mm, 3.5 x 38 mm, 4.0 x 18 mm, 4.0 x 33 mm) were implanted from distal to proximal in the rca.Unspecified non-compliant (nc) balloons were used to post-dilate the stents.On angiography, a perforation was observed in the mid rca.It is unknown at what point the perforation occurred or what device caused the perforation; however, as the 3.5 x 38 mm xience alpine stent was in the mid rca it is believed that the perforation occurred at its location.A 4.0 x 16 mm graftmaster stent was deployed in the mid rca; however, did not seal the perforation.A 5.0 nc balloon was advanced to expand the graftmaster a little more; however, there was still a leak observed.Pericardiocentesis was performed but the patient starting crashing.The patient was experiencing right ventricular failure (heart failure); therefore, the patient's chest was opened and cardiac massage was performed.The patient was placed on an extracorporeal membrane oxygenation machine and transferred to (b)(6) where they underwent coronary artery bypass.The deployed stents and the deployed graftmaster stent were removed during this procedure.The patient is reported to be alive.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: 6665459
• Report Number: 2024168-2017-05343
• Device Sequence Number: 1972212
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: (01)08717648199578(17)200319(10)7030841
• 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
• Device Explanted 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): 06/23/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2020
• Device Catalogue Number: 1125350-38
• Device Lot Number: 7030841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 06/23/2017
• 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: Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 69 YR