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

Catalog Number	1074250-12
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	03/10/2018
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 product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effect of dissection is listed in xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported failure to advance appear to be related to circumstances of the procedure.There is no indication of a product quality issue.
Event or Problem Description
It was reported that the patient was hospitalized in the intense care unit (icu) with st segment elevation myocardial infarction (stemi) from the diffused mid-proximal and nearly occluded mid right coronary artery (rca).After pre-dilatation with an unspecified balloon catheter, the 2.5 x 33 mm xience xpedition stent delivery system (sds) was advanced but failed to cross the lesion due to the anatomy.The device was removed and a shorter 2.5 x 12 mm xience xpedition sds with a guideliner was attempted; however, proximal to the target lesion a vessel dissection occurred.A 2.25 x 8 mm xience xpedition stent was successfully implanted proximal to the target lesion.The dissection was treated with balloon angioplasty and the patient was put on medical management.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: 7387183
• Report Number: 2024168-2018-02365
• Device Sequence Number: 16339795
• Product Code: NIQ
• UDI-Device Identifier: 08717648162121
• UDI-Public: 08717648162121
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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: 08/18/2019
• Device Catalogue Number: 1074250-12
• Device Lot Number: 6080941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/30/2018
• 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: 75 YR
• Patient Weight: 58