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

Catalog Number	1125350-23
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis as it remains in the patient.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulty to position to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The 3.0 x 08 xience alpine is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified distal left anterior descending artery (lad).The patient presented with a non-st elevated myocardial infarction (nstemi).A 3.5 x 23 mm xience alpine stent was implanted in the mid left anterior descending artery and a 3.5 x 15 mm xience alpine stent was implanted in the proximal lad overlapping the 3.5 x 23 mm stent.Post dilatation was performed with a 3.5 x 08 mm balloon catheter.Angiography confirmed a dissection at the distal end of the 3.5 x 23 mm xience alpine stent.Therefore, a 3.0 x 08 mm xience alpine stent was advanced to the 3.5 x 23 mm xience alpine stent.However, the 3.0 x 08 mm xience alpine stent failed to cross due to the anatomy and the implanted stent.Therefore, the stent delivery system was removed and a guideliner and an unspecified guide wire was advanced and the same 3.0 x 08 mm xience alpine stent was reinserted, but it still could not advance past the deployed stent.During removal, the stent dislodged in the implanted stent.Access was lost and could not be re-established.The procedure already lasted for 2 hours so an intra-aortic balloon pump was placed, and the patient was taken to emergent bypass surgery.There was no clinically significant delay in the procedure.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: 6591954
• Report Number: 2024168-2017-04507
• Device Sequence Number: 13579929
• Product Code: NIQ
• UDI-Device Identifier: 08717648199547
• UDI-Public: (01)08717648199547
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/25/2017

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: 1125350-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/25/2017
• 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; Required Intervention; Disability
• Patient Age: 72 YR