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

Catalog Number	1074225-28
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/01/2016
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.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 stenosis is listed in the xience xpedition everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2014, xience xpedition 2.25 x 28 mm and a 2.25 x 23 mm stents were implanted in the restenosed proximal to mid right coronary artery (rca) lesion.The patient was on dual anti-platelet therapy (dapt) consisting of aspirin 100 mg/day ongoing from prior to the index procedure, clopidogrel 75 mg/day from prior to the index procedure to (b)(6) 2016 and prasugrel 3.75 mg/day ongoing from (b)(6) 2016.On (b)(6) 2015, restenosis of the xience xpedition 2.25 x 28 mm stent was noted and was reported accordingly on 12/22/2015.On (b)(6) 2016, restenosis of the xience xpedition 2.25 x 28 mm stent in rca was noted.The restenosed lesion was treated with balloon angioplasty on (b)(6) 2016 and the patient condition was improved on (b)(6) 2016.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 6477305
• Report Number: 2024168-2017-02986
• Device Sequence Number: 13572945
• Product Code: NIQ
• UDI-Device Identifier: 08717648162060
• UDI-Public: (01)08717648162060(17)160713(10)4070941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 07/13/2016
• Device Catalogue Number: 1074225-28
• Device Lot Number: 4070941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/10/2017
• 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: STENT: XIENCE XPEDITION 2.25X23; STENT: XIENCE XPEDITION 2.25X23
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 64