MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235350-18
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Respiratory Failure (2484)
Date of Event	11/27/2016
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 evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.The reported patient effects of hypotension and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient presented with non-st-elevation myocardial infarction (nstemi).The procedure was to treat a lesion in the proximal left anterior descending artery with 70% stenosis.The lesion was predilated using a 3.5x15mm non-abbott balloon catheter.A 3.5x18mm absorb gt1 rx scaffold delivery system (sds) was implanted without issue.Post dilatation was performed using an unspecified 3.75x15 non-compliant (nc) balloon catheter that was inflated to nominal pressure.During the procedure the physician was working on a different lesion.The patient became symptomatic with a blood pressure drop and trouble breathing.The patient was intubated to help with breathing and given heparin to properly coagulate.The physician noted the area around the scaffold was cloudy due to thrombosis.An unspecified nc balloon catheter was used to successfully treat the thrombosis.The patient is still hospitalized.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6167907
• Report Number: 2024168-2016-08809
• Device Sequence Number: 730868
• Product Code: PNY
• UDI-Device Identifier: 08717648213120
• UDI-Public: (01)08717648213120(17)170718(10)6071961
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2016

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 Expiration Date: 07/18/2017
• Device Catalogue Number: 1235350-18
• Device Lot Number: 6071961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/12/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR