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

Catalog Number	1125350-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: stent: 2.8 x 19 mm graftmaster (x2), scaffold: 3.0 x 23 mm absorb gt1.The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported stent migration was likely due to interaction with the deployed graftmaster stents.The treatment appears to be related to the operational context of the procedure as dilatation of the left main was again performed with a 2.5 x 12 mm trek balloon.A new 3.5 x 12 mm xience alpine stent was deployed in the ostial of the left main and post-dilated with a 4.0 x 12 balloon.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 2.80 x 19 graftmaster and 3.0 x 23 absorb gt1 are being filed under separate medwatch reports.
Event or Problem Description
It was reported that pre-dilatation of the ostial left main was performed with a 3.0 x 12 mm trek balloon.Then, a 3.5 x 12 mm xience alpine stent was deployed at the ostial left main and post-dilated with a non-compliant balloon.A 3.0 x 23 mm absorb gt1 scaffold was implanted in the mid lad lesion; however, a perforation occurred.Multiple attempts were made to balloon tamponade it; however, the perforation remained.Therefore, a 2.8 x 19 mm graftmaster stent was deployed to treat the perforation.This helped to decrease the amount of extravasation and perforation, but mild extravasation remained; therefore, a second 2.8 x 19 mm graftmaster was deployed with 1 mm overlap.During this time, pericardiocentesis was performed using a 5 fr micropuncture sheath.Improvement was noted in the patient's hemodynamics with the placement of pericardiocentesis drain and the graftmaster stents; however, post angiography revealed that the xience alpine stent had migrated, likely due to interaction when the graftmaster stents were deployed.Dilatation of the left main was again performed with a 2.5 x 12 mm trek balloon.A new 3.5 x 12 mm xience alpine stent was deployed in the ostial of the left main and post-dilated with a 4.0 x 12 balloon.Intravascular ultrasound (ivus) revealed excellent stent apposition.The pericardiocentesis drain remained in the patient and the patient was sent to the intensive care unit overnight for monitoring and if there was no change in the accumulation of fluid, the drain was to be removed.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: 6963292
• Report Number: 2024168-2017-08344
• Device Sequence Number: 16323259
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: 08717648199516
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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 Catalogue Number: 1125350-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/19/2017
• 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: 72 YR