MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

Catalog Number	1007822-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2017
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 analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported failure to advance, stent dislodgement and foreign body in patient appear to be related to circumstances of the procedure.Based on the information reviewed, 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 the procedure was to treat a lesion located in the heavily calcified, 90% stenosed, mid right coronary artery.After placement of a jr4 6fr guiding catheter, the decision was made to exchange it for an ar1 guide catheter.A 2.0 mm trek balloon was used for predilatation.The 2.75 x 12 mm rx vision stent delivery system (sds) was advanced in an attempt to cross the lesion; however, it failed to cross.Additional pre-dilatation was performed with an nc trek balloon, followed by the advancement of a 6fr guideliner.An attempt was made to cross with a 2.25 x 15 mm mini vision sds; however, during positioning attempts, the stent implant dislodged from the balloon into the anatomy.No attempts were made to retrieve the stent implant which remains in the patient.No additional information was provided.

• Brand Name: MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6590477
• Report Number: 2024168-2017-04469
• Device Sequence Number: 10972355
• Product Code: MAF
• UDI-Device Identifier: 08717648049453
• UDI-Public: (01)08717648049453(17)191231(10)7010941
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• 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): 05/25/2017

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: 12/31/2019
• Device Catalogue Number: 1007822-15
• Device Lot Number: 7010941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 05/25/2017
• 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: GUIDING CATHETER: AR1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 86