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

Catalog Number	1074300-23
Health Effect - Clinical Codes	Thrombosis (2100); Stenosis (2263)
Date of Event	11/05/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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.Thrombosis and stenosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.The 3.5x15 xience prime referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2013, a 3.5x15mm xience prime stent was implanted in the distal left circumflex (cx) coronary artery lesion.On (b)(6) 2013, 75% stenosis was noted at the distal cx, 3.5x15mm xience prime stent at the stents proximal edge.A 3.0x23mm xience xpedition stent was implanted and balloon angioplasty was performed as treatment.On (b)(6) 2015, restenosis of the distal cx was noted in both distal cx (3.5x15mm xience prime and 3.0x23mm xience xpedition) stents.On (b)(6) 2015, the patient was hospitalized.Per imaging, organized tissue such as a blood clot was noted in the distal cx xience xpedition stent.It is unknown if thrombus was in the distal cx xience prime stent.Dilatation was performed using a cutting balloon and a non-abbott stent was implanted as treatment.On (b)(6) 2016, restenosis of the distal cx was again noted.On (b)(6) 2016 the patient was hospitalized and a drug eluting stent was implanted as treatment.On (b)(6) 2016 the event resolved.There was no additional information 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: 6056179
• Report Number: 2024168-2016-07300
• Device Sequence Number: 16550680
• Product Code: NIQ
• UDI-Device Identifier: 08717648162350
• UDI-Public: (01)08717648162350
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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 Catalogue Number: 1074300-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2016
• Initial Report FDA Received Date: 10/25/2016
• 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: XIENCE PRIME STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 83