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

Catalog Number	1125350-38
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: guide wire: sion, sion blue; guide catheter: hyperion sal 7f, stent: xience alpine 3.0x18mm, 4.0 x28mm, graftmaster 2.8x19mm.The device was not returned for analysis.However, hypotension and arterial perforation are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined a conclusive cause for the reported difficult to position cannot be determined.Additionally, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.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 identified no other similar incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 2.8 x 19 graftmaster is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and moderately calcified, de novo and eccentric proximal right coronary artery (rca) that was 90% stenosed.Pre-dilatation was performed with two non-abbott balloon catheters.A 3.0 x 18 mm xience alpine stent was deployed in the distal rca, a 3.5 x 38 mm xience alpine stent was deployed in the mid rca and a 4.0 x 28 mm xience alpine stent was deployed in the proximal rca.The 3.0 x 18 mm and 3.5 x 38 mm stents were not overlapped, the 3.5 x 38 mm and 4.0 x 28 mm were overlapped.Intravascular ultrasound (ivus) was used multiple times before and after deploying the stents.It was confirmed there was no malposition of the 3.5 x 38 mm xience alpine; however, it was oval shaped due to the calcified lesion.Angiography was performed due to the patient blood pressure declining and a perforation was noted where the 3.5 x 38 mm xience alpine was implanted.Pericardiocentesis was performed and a 2.8 x 19 mm graftmaster covered stent system was advanced but could not cross through the implanted 3.5 x 38 mm xience alpine and when removed from the anatomy the edge of the stent was flared.A guideliner was advanced and a 2.8 x 16 mm graftmaster was deployed to cover the perforation.There was no leak noted.An additional 3.5 x 16 mm graftmaster stent was deployed overlapping the proximal end of the 3.5 x 38 mm xience alpine.Post-dilatation was performed with a non-abbott balloon catheter and ivus was performed to confirm there was no blood leak which completed the procedure.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: 6393818
• Report Number: 2024168-2017-01988
• Device Sequence Number: 13461337
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: (01)08717648199578(17)191108(10)6110141
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

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: 11/08/2019
• Device Catalogue Number: 1125350-38
• Device Lot Number: 6110141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/09/2017
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 58