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

Catalog Number	1125400-15
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Date of Event	04/11/2017
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 medical devices continued: guide wire: medtronic zinger; stent: xience alpine (4.0x23, 4.0x15) the device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effect, 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 other two xience alpines (4.0 x 23 and 4.0 x 15) referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified right coronary artery (rca).A 4.0 x 38 mm xience alpine stent delivery system was being advanced; however, the device could not cross the lesion due to the anatomy.A 4.0 x 15 mm xience alpine stent was deployed in the distal rca.A 4.0 x 23 mm xience alpine stent was deployed in the mid rca, overlapping the distal stent.A 4.0 x 15 mm xience alpine stent was deployed in the proximal rca, overlapping the middle stent.There were no issues during deployment; however, when attempting to remove the non-abbott guide wire, the wire was stuck in the stents and could not be removed.Several attempts were made to remove the guide wire with balloon catheters, but it could not be removed.Force was applied to try to remove the guide wire, but it started crumpling the proximal and middle stents.The physician pulled hard on the guide wire and it separated leaving approximately 2 cm of the guide wire in the rca and sticking out of the ostium.The patient had st elevation and angiography confirmed thrombosis in the entire length of the rca.The patient was prepped and sent for bypass surgery.There was a 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: 6517080
• Report Number: 2024168-2017-03544
• Device Sequence Number: 1641466
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: (01)08717648199615(17)200213(10)7020241
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/24/2017

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: 02/13/2020
• Device Catalogue Number: 1125400-15
• Device Lot Number: 7020241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE CONCOMITANT MEDICAL DEVICES UNDER H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 116