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

Catalog Number	1125400-12
Health Effect - Clinical Codes	Angina (1710); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: guide wire: mailman, runthrough, sheath: 6 fr , 5fr jacky, 7fr , stent: 4.0 x 38 mm xience alpine.The device was not returned for evaluation.The reported patient effects of angina, hypotension, perforation and cardiac tamponade are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, 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 of the device.The 4.0 x 38 mm xience alpine is being filed under a separate medwatch report.
Event or Problem Description
It was reported the procedure was to treat an eccentric lesion with heavy calcification in the proximal to mid right coronary artery.A 4.0 x 38 mm xience stent was successfully deployed in the more distal segment of the long mid lesion and then the rest of the lesion was covered with a 4.0 x 12 mm xience stent, overlapping the previously deployed stent.Post-dilatation of the middle segment was performed using the stent delivery balloon, but subsequent angiography showed a severe eccentric coronary rupture.The physician commented that the perforation did not occur because of the stents, but because of the calcification and frailty of the vessel.The patient did have significant chest discomfort.A 4.0 mm non-compliant (nc) balloon was inflated across the lesion for tamponade purposes with significant improvement after several inflations.An emergent echocardiogram revealed a moderate concentric pericardial effusion with tamponade features, accompanied by hypotension and requirement of medication.Therefore, a 3.5 x 19 mm graftmaster was used to cover the perforation successfully.Post-dilatation was performed with a 4.0 mm nc balloon.Angiography showed a seal of the perforation.A 4.0 x 8 mm xience was successfully deployed across the ostium and post-dilated.Then, pericardiocentesis was performed with dramatic and immediate response in blood pressure.Angiography revealed very good results with no residual stenosis with good timi 3 flow and no dissections or extravasation.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: 7144633
• Report Number: 2024168-2017-10099
• Device Sequence Number: 939848
• Product Code: NIQ
• UDI-Device Identifier: 08717648199608
• UDI-Public: 08717648199608
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/22/2017

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: 02/02/2020
• Device Catalogue Number: 1125400-12
• Device Lot Number: 7012541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/22/2017
• 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: 57 YR